Committee Report

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115th Congress } { Rept. 115-748
HOUSE OF REPRESENTATIVES
2d Session } { Part 1
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EVERY PRESCRIPTION CONVEYED SECURELY ACT
_______
June 12, 2018.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Walden, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 3528]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 3528) to amend title XVIII of the Social
Security Act to require e-prescribing for coverage under part D
of the Medicare program of prescription drugs that are
controlled substances, having considered the same, report
favorably thereon with an amendment and recommend that the bill
as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 3
Background and Need for Legislation.............................. 3
Committee Action................................................. 3
Committee Votes.................................................. 4
Oversight Findings and Recommendations........................... 4
New Budget Authority, Entitlement Authority, and Tax Expenditures 4
Congressional Budget Office Estimate............................. 4
Federal Mandates Statement....................................... 26
Statement of General Performance Goals and Objectives............ 26
Duplication of Federal Programs.................................. 26
Committee Cost Estimate.......................................... 26
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 27
Disclosure of Directed Rule Makings.............................. 27
Advisory Committee Statement..................................... 27
Applicability to Legislative Branch.............................. 27
Section-by-Section Analysis of the Legislation................... 27
Changes in Existing Law Made by the Bill, as Reported............ 27
Exchange of Letters with Additional Committees of Referral....... 51
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Every Prescription Conveyed Securely
Act''.
SEC. 2. REQUIRING E-PRESCRIBING FOR COVERAGE OF COVERED PART D
CONTROLLED SUBSTANCES.
(a) In General.--Section 1860D-4(e) of the Social Security Act (42
U.S.C. 1395w-104(e)) is amended by adding at the end the following:
``(7) Requirement of e-prescribing for controlled
substances.--
``(A) In general.--Subject to subparagraph (B), a
prescription for a covered part D drug under a
prescription drug plan (or under an MA-PD plan) for a
schedule II, III, IV, or V controlled substance shall
be transmitted by a health care practitioner
electronically in accordance with an electronic
prescription drug program that meets the requirements
of paragraph (2).
``(B) Exception for certain circumstances.--The
Secretary shall, pursuant to rulemaking, specify
circumstances with respect to which the Secretary may
waive the requirement under subparagraph (A), with
respect to a covered part D drug, including in the case
of--
``(i) a prescription issued when the
practitioner and dispenser are the same entity;
``(ii) a prescription issued that cannot be
transmitted electronically under the most
recently implemented version of the National
Council for Prescription Drug Programs SCRIPT
Standard;
``(iii) a prescription issued by a
practitioner who has received a waiver or a
renewal thereof for a specified period
determined by the Secretary, not to exceed one
year, from the requirement to use electronic
prescribing, pursuant to a process established
by regulation by the Secretary, due to
demonstrated economic hardship, technological
limitations that are not reasonably within the
control of the practitioner, or other
exceptional circumstance demonstrated by the
practitioner;
``(iv) a prescription issued by a
practitioner under circumstances in which,
notwithstanding the practitioner's ability to
submit a prescription electronically as
required by this subsection, such practitioner
reasonably determines that it would be
impractical for the individual involved to
obtain substances prescribed by electronic
prescription in a timely manner, and such delay
would adversely impact the individual's medical
condition involved;
``(v) a prescription issued by a practitioner
allowing for the dispensing of a non-patient
specific prescription pursuant to a standing
order, approved protocol for drug therapy,
collaborative drug management, or comprehensive
medication management, in response to a public
health emergency, or other circumstances where
the practitioner may issue a non-patient
specific prescription;
``(vi) a prescription issued by a
practitioner prescribing a drug under a
research protocol;
``(vii) a prescription issued by a
practitioner for a drug for which the Food and
Drug Administration requires a prescription to
contain elements that are not able to be
included in electronic prescribing, such as a
drug with risk evaluation and mitigation
strategies that include elements to assure safe
use; and
``(viii) a prescription issued by a
practitioner for an individual who--
``(I) receives hospice care under
this title; or
``(II) is a resident of a skilled
nursing facility (as defined in section
1819(a)), or a medical institution or
nursing facility for which payment is
made for an institutionalized
individual under section 1902(q)(1)(B),
for which frequently abused drugs are
dispensed for residents through a
contract with a single pharmacy, as
determined by the Secretary in
accordance with this paragraph.
``(C) Dispensing.--Nothing in this paragraph shall be
construed as requiring a sponsor of a prescription drug
plan under this part, MA organization offering an MA-PD
plan under part C, or a pharmacist to verify that a
practitioner, with respect to a prescription for a
covered part D drug, has a waiver (or is otherwise
exempt) under subparagraph (B) from the requirement
under subparagraph (A). Nothing in this paragraph shall
be construed as affecting the ability of the plan to
cover or the pharmacists' ability to continue to
dispense covered part D drugs from otherwise valid
written, oral or fax prescriptions that are consistent
with laws and regulations. Nothing in this paragraph
shall be construed as affecting the ability of the
beneficiary involved to designate a particular pharmacy
to dispense a prescribed drug to the extent consistent
with the requirements under subsection (b)(1) and under
this paragraph.
``(D) Enforcement.--The Secretary shall, pursuant to
rulemaking, have authority to enforce and specify
appropriate penalties for non-compliance with the
requirement under subparagraph (A).''.
(b) Effective Date.--The amendment made by subsection (a) shall apply
to coverage of drugs prescribed on or after January 1, 2021.
Purpose and Summary
H.R. 3528, Every Prescription Conveyed Securely Act, was
introduced on July 28, 2017, by Rep. Katherine Clark (D-MA) and
Rep. Markwayne Mullin (R-OK) to require e-prescribing for
coverage of prescribed controlled substances under the Medicare
Part D program.
Background and Need for Legislation
The Medicare program serves as the healthcare coverage
provider to over 58 million beneficiaries. This number is
projected to rise to over 80 million by 2030. In serving the
over age 65 population, Medicare accounts for a large share of
total opioid prescriptions. In 2016, one out of every three
beneficiaries was prescribed an opioid through Medicare Part D.
In total, this equates to almost 80 million prescriptions and
$4 billion in Medicare Part D spending. While many Medicare
beneficiaries with serious pain-related conditions are being
properly prescribed opioids, there is mounting evidence of
opioid misuse in the Medicare system. As more seniors and
individuals with disabilities come into the program, the
challenges of fraud, misuse, and abuse will only increase.
This bill seeks to deter prescription fraud and the
diversion of opioids by better securing the prescriptions of
controlled substances covered under Medicare Part D by
requiring the use of electronic prescribing for such drugs.
This bill ensures that prescriptions for controlled substances
covered under Medicare Part D are transmitted securely from the
prescriber to the dispensing pharmacy and reduces the potential
for fraudulent prescriptions.
Committee Action
On April 11 and 12, 2018, the Subcommittee on Health held a
hearing entitled ``Combating the Opioid Crisis: Improving the
Ability of Medicare and Medicaid to Provide Care for Patients''
to review legislation related to the opioid epidemic. The
Subcommittee received testimony from:
Kimberly Brandt, Principal Deputy
Administrator for Operations, Centers for Medicare and
Medicaid Services, U.S. Department of Health and Human
Services;
Michael Botticelli, Executive Director,
Grayken Center for Addiction, Boston Medical Center;
Toby Douglas, Senior Vice President,
Medicaid Solutions, Centene Corporation;
David Guth, CEO, Centerstone;
John Kravitz, CIO, Geisinger Health System;
and,
Sam Srivastava, CEO, Magellan Health.
On April 25, 2018, the Subcommittee on Health met in open
markup session and forwarded H.R. 3528, as amended, to the full
Committee by a voice vote. On May 9, 2018, the full Committee
on Energy and Commerce met in open markup session and ordered
H.R. 3528, as amended, favorable reported to the House by a
voice vote.
Committee Votes
Clause 3(b) of rule XIII requires the Committee to list the
record votes on the motion to report legislation and amendments
thereto. There were no record votes taken in connection with
ordering H.R. 3528 reported.
Oversight Findings and Recommendations
Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of
rule XIII, the Committee held a hearing and made findings that
are reflected in this report.
New Budget Authority, Entitlement Authority, and Tax Expenditures
Pursuant to clause 3(c)(2) of rule XIII, the Committee
finds that H.R. 3528 would result in no new or increased budget
authority, entitlement authority, or tax expenditures or
revenues.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII, the following is
the cost estimate provided by the Congressional Budget Office
pursuant to section 402 of the Congressional Budget Act of
1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, June 6, 2018.
Hon. Greg Walden,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed document with cost estimates for the
opioid-related legislation ordered to be reported on May 9 and
May 17, 2018.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contacts are Tom Bradley
and Chad Chirico.
Sincerely,
Mark P. Hadley
(For Keith Hall, Director).
Enclosure.
Opioid Legislation
Summary: On May 9 and May 17, 2018, the House Committee on
Energy and Commerce ordered 59 bills to be reported related to
the nation's response to the opioid epidemic. Generally, the
bills would:
Provide grants to facilities and providers
that treat people with substance use disorders,
Direct various agencies within the
Department of Health and Human Services (HHS) to
explore nonopioid approaches to treating pain and to
educate providers about those alternatives,
Modify requirements under Medicaid and
Medicare for prescribing controlled substances,
Expand Medicaid coverage for substance abuse
treatment, and
Direct the Food and Drug Administration
(FDA) to modify its oversight of opioid drugs and other
medications that are used to manage pain.
Because of the large number of related bills ordered
reported by the Committee, CBO is publishing a single
comprehensive document that includes estimates for each piece
of legislation.
CBO estimates that enacting 20 of the bills would affect
direct spending, and 2 of the bills would affect revenues;
therefore, pay-as-you-go procedures apply for those bills.
CBO estimates that enacting H.R. 4998, the Health Insurance
for Former Foster Youth Act, would increase net direct spending
by more than $2.5 billion and on-budget deficits by more than
$5 billion in at least one of the four consecutive 10-year
periods beginning in 2029. None of the remaining 58 bills
included in this estimate would increase net direct spending by
more than $2.5 billion or on-budget deficits by more than $5
billion in any of the four consecutive 10-year periods
beginning in 2029.
One of the bills reviewed for this document, H.R. 5795,
would impose both intergovernmental and private-sector mandates
as defined in the Unfunded Mandates Reform Act (UMRA). CBO
estimates that the costs of those mandates on public and
private entities would fall below the thresholds in UMRA ($80
million and $160 million, respectively, in 2018, adjusted
annually for inflation). Five bills, H.R. 5228, H.R. 5333, H.R.
5554, H.R. 5687, and H.R. 5811, would impose private-sector
mandates as defined in UMRA. CBO estimates that the costs of
the mandates in three of the bills (H.R. 5333, H.R. 5554, and
H.R. 5811) would not exceed the UMRA threshold for private
entities. Because CBO is uncertain how federal agencies would
implement new authority granted in the other two bills, H.R.
5228 and H.R. 5687, CBO cannot determine whether the costs of
those mandates would exceed the UMRA threshold.
Estimated cost to the Federal Government: The estimates in
this document do not include the effects of interactions among
the bills. If all 59 bills were combined and enacted as one
piece of legislation, the budgetary effects would be different
from the sum of the estimates in this document, although CBO
expects that any such differences would be small. The costs of
this legislation fall within budget functions 550 (health), 570
(Medicare), 750 (administration of justice), and 800 (general
government).
Basis of estimate: For this estimate, CBO assumes that all
of the legislation will be enacted late in 2018 and that
authorized and estimated amounts will be appropriated each
year. Outlays for discretionary programs are estimated based on
historical spending patterns for similar programs.
Uncertainty
CBO aims to produce estimates that generally reflect the
middle of a range of the most likely budgetary outcomes that
would result if the legislation was enacted. Because data on
the utilization of mental health and substance abuse treatment
under Medicaid and Medicare is scarce, CBO cannot precisely
predict how patients or providers would respond to some policy
changes or what budgetary effects would result. In addition,
several of the bills would give the Department of Health and
Human Services (HHS) considerable latitude in designing and
implementing policies. Budgetary effects could differ from
those provided in CBO's analyses depending on those decisions.
Direct spending and revenues
Table 1 lists the 22 bills of the 59 ordered to be reported
that would affect direct spending or revenues.
TABLE 1.--ESTIMATED CHANGES IN MANDATORY SPENDING AND REVENUES
--------------------------------------------------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
------------------------------------------------------------------------------------------------------------------------
2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2019-2023 2019-2028
--------------------------------------------------------------------------------------------------------------------------------------------------------
INCREASES OR DECREASES (-) IN DIRECT SPENDING
Legislation Primarily Affecting
Medicaid:
H.R. 1925, At-Risk Youth 0 * 5 5 5 10 10 10 10 10 10 25 75
Medicaid Protection Act of
2017......................
H.R. 4998, Health Insurance 0 0 0 0 0 * 10 21 33 46 61 * 171
for Former Foster Youth
Act.......................
H.R. 5477, Rural 0 13 35 58 68 83 27 9 3 3 3 256 301
Development of Opioid
Capacity Services Act.....
H.R. 5583, a bill to amend 0 * * * * * * * * * * * *
title XI of the Social
Security Act to require
States to annually report
on certain adult health
quality measures, and for
other purposes............
H.R. 5797, IMD CARE Act.... 0 38 158 251 265 279 0 0 0 0 0 991 991
H.R. 5799, Medicaid DRUG 0 * * 1 1 1 1 1 1 1 1 2 5
Improvement Acta..........
H.R. 5801 Medicaid 0 * * * * * * * * * * * *
Providers Are Required To
Note Experiences in Record
Systems to Help In-Need
Patients (PARTNERSHIP)
Acta......................
H.R. 5808, Medicaid 0 * -1 -1 -1 -1 -2 -2 -2 -2 -2 -4 -13
Pharmaceutical Home Act of
2018a.....................
H.R. 5810, Medicaid Health 0 94 58 62 56 52 48 43 38 32 25 323 509
HOME Act..................
Legislation Primarily Affecting
Medicare:
H.R. 3528, Every 0 0 0 -24 -35 -33 -30 -33 -32 -31 -32 -92 -250
Prescription Conveyed
Securely Act..............
H.R. 4841, Standardizing 0 0 0 * * * * * * * * * *
Electronic Prior
Authorization for Safe
Prescribing Act of 2018...
H.R. 5603, Access to 0 2 * * * 1 1 1 2 2 2 3 11
Telehealth Services for
Opioid Use Disorders Act..
H.R. 5605, Advancing High 0 0 0 15 26 24 23 23 10 1 * 65 122
Quality Treatment for
Opioid Use Disorders in
Medicare Act..............
H.R. 5675, a bill to amend 0 0 0 -6 -7 -7 -7 -8 -9 -9 -11 -20 -64
title XVIII of the Social
Security Act to require
prescription drug plan
sponsors under the
Medicare program to
establish drug management
programs for at-risk
beneficiaries.............
H.R. 5684, Protecting 0 0 0 * * * * * * * * * *
Seniors From Opioid Abuse
Act.......................
H.R. 5796, Responsible 0 10 25 50 10 5 0 0 0 0 0 100 100
Education Achieves Care
and Healthy Outcomes for
Users' Treatment Act of
2018......................
H.R. 5798, Opioid Screening 0 0 * 1 1 1 1 1 1 1 1 2 5
and Chronic Pain
Management Alternatives
for Seniors Act...........
H.R. 5804, Post-Surgical 0 0 25 30 25 20 10 5 0 0 0 100 115
Injections as an Opioid
Alternative Acta..........
H.R. 5809, Postoperative 0 0 0 0 10 15 20 25 30 35 45 25 180
Opioid Prevention Act of
2018......................
Legislation Primarily Affecting
the Food and Drug
Administration:
H.R. 5333, Over-the-Counter 0 0 * * * * * * * * * * *
Monograph Safety,
Innovation, and Reform Act
of 2018a..................
INCREASES OR DECREASES (-) IN REVENUESb
H.R. 5752, Stop Illicit 0 * * * * * * * * * * * *
Drug Importation Act of
2018......................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between -$500,000 and $500,000. Budget authority is equivalent to outlays.
aThis bill also would affect spending subject to appropriation.
bOne additional bill, H.R. 5228, the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act, would have a negligible effect on revenues.
Legislation Primarily Affecting Medicaid. The following
nine bills would affect direct spending for the Medicaid
program.
H.R. 1925, the At-Risk Youth Medicaid Protection Act of
2017, would require states to suspend, rather than terminate,
Medicaid eligibility for juvenile enrollees (generally under 21
years of age) who become inmates of public correctional
institutions. States also would have to redetermine those
enrollees' Medicaid eligibility before their release and
restore their coverage upon release if they qualify for the
program. States would be required to process Medicaid
applications submitted by or on behalf of juveniles in public
correctional institutions who were not enrolled in Medicaid
before becoming inmates and ensure that Medicaid coverage is
provided when they are released if they are found to be
eligible. On the basis of an analysis of juvenile incarceration
trends and of the per enrollee spending for Medicaid foster
care children, who have a similar health profile to
incarcerated juveniles, CBO estimates that implementing the
bill would cost $75 million over the 2019-2028 period.
H.R. 4998, the Health Insurance for Former Foster Youth
Act, would require states to provide Medicaid coverage to
adults up to age 25 who had aged out of foster care in any
state. Under current law, such coverage is mandatory only if
the former foster care youth has aged out in the state in which
the individual applies for coverage. The policy also would
apply to former foster children who had been in foster care
upon turning 14 years of age but subsequently left foster care
to enter into a legal guardianship with a kinship caregiver.
The provisions would take effect respect for foster youth who
turn 18 on or after January 1, 2023. On the basis of spending
for Medicaid foster care children and data from the Census
Bureau regarding annual migration rates between states, CBO
estimates that implementing the bill would cost $171 million
over the 2019-2028 period.
H.R. 5477, the Rural Development of Opioid Capacity
Services Act, would direct the Secretary of HHS to conduct a
five-year demonstration to increase the number and ability of
providers participating in Medicaid to provide treatment for
substance use disorders. On the basis of an analysis of federal
and state spending for treatment of substance use disorders and
the prevalence of such disorders, CBO estimates that enacting
the bill would increase direct spending by $301 million over
the 2019-2028 period.
H.R. 5583, a bill to amend title XI of the Social Security
Act to require States to annually report on certain adult
health quality measures, and for other purposes, would require
states to include behavioral health indicators in their annual
reports on the quality of care under Medicaid. Although the
bill would add a requirement for states, CBO estimates that its
enactment would not have a significant budgetary effect because
most states have systems in place for reporting such measures
to the federal government.
H.R. 5797, the IMD CARE Act, would expand Medicaid coverage
for people with opioid use disorder who are in institutions for
mental disease (IMDs) for up to 30 days per year. Under a
current-law policy known as the IMD exclusion, the federal
government generally does not make matching payments to state
Medicaid programs for most services provided by IMDs to adults
between the ages of 21 and 64. Recent administrative changes
have made federal financing for IMDs available in limited
circumstances, but the statutory prohibition remains in place.
CBO analyzed several data sets, primarily those collected by
the Substance Abuse and Mental Health Services Administration
(SAMHSA), to estimate current federal spending under Medicaid
for IMD services and to estimate spending under H.R. 5797.
Using that analysis, CBO estimates that enacting H.R. 5797
would increase direct spending by $991 million over the 2019-
2028 period.
H.R. 5799, the Medicaid DRUG Improvement Act, would require
state Medicaid programs to implement additional reviews of
opioid prescriptions, monitor concurrent prescribing of opioids
and certain other drugs, and monitor use of antipsychotic drugs
by children. CBO estimates that the bill would increase direct
spending by $5 million over 2019-2028 period to cover the
administrative costs of complying with those requirements. On
the basis of stakeholder feedback, CBO expects that the bill
would not have a significant effect on Medicaid spending for
prescription drugs because many of the bill's requirements
would duplicate current efforts to curb opioid and
antipsychotic drug use. (If enacted, H.R. 5799 also would
affect spending subject to appropriation; CBO has not completed
an estimate of that amount.)
H.R. 5801, the Medicaid Providers Are Required To Note
Experiences in Record Systems to Help In-Need Patients
(PARTNERSHIP) Act, would require providers who are permitted to
prescribe controlled substances and who participate in Medicaid
to query prescription drug monitoring programs (PDMPs) before
prescribing controlled substances to Medicaid patients. PDMPs
are statewide electronic databases that collect data on
controlled substances dispensed in the state. The bill also
would require PDMPs to comply with certain data and system
criteria, and it would provide additional federal matching
funds to certain states to help cover administrative costs. On
the basis of a literature review and stakeholder feedback, CBO
estimates that the net budgetary effect of enacting H.R. 5801
would be insignificant. Costs for states to come into
compliance with the systems and administrative requirements
would be roughly offset by savings from small reductions in the
number of controlled substances paid for by Medicaid under the
proposal. (If enacted, H.R. 5801 also would affect spending
subject to appropriation; CBO has not completed an estimate of
that amount.)
H.R. 5808, the Medicaid Pharmaceutical Home Act of 2018,
would require state Medicaid programs to operate pharmacy
programs that would identify people at high risk of abusing
controlled substances and require those patients to use a
limited number of providers and pharmacies. Although nearly all
state Medicaid programs currently meet such a requirement, a
small number of high-risk Medicaid beneficiaries are not now
monitored. Based on an analysis of information about similar
state and federal programs, CBO estimates that net Medicaid
spending under the bill would decrease by $13 million over the
2019-2028 period. That amount represents a small increase in
administrative costs and a small reduction in the number of
controlled substances paid for by Medicaid under the proposal.
(If enacted, H.R. 5808 also would affect spending subject to
appropriation; CBO has not completed an estimate of that
amount.)
H.R. 5810, the Medicaid Health HOME Act, would allow states
to receive six months of enhanced federal Medicaid funding for
programs that coordinate care for people with substance use
disorders. Based on enrollment and spending data from states
that currently participate in Medicaid's Health Homes program,
CBO estimates that the expansion would cost approximately $469
million over the 2019-2028 period. The bill also would require
states to cover all FDA-approved drugs used in medication-
assisted treatment for five years, although states could seek a
waiver from that requirement. (Medication-assisted treatment
combines behavioral therapy and pharmaceutical treatment for
substance use disorders.) Under current law, states already
cover most FDA-approved drugs used in such programs in some
capacity, although a few exclude methadone dispensed by opioid
treatment programs. CBO estimates that a small share of those
states would begin to cover methadone if this bill was enacted
at a federal cost of about $39 million over the 2019-2028
period. In sum, CBO estimates that the enacting H.R. 5810 would
increase direct spending by $509 million over the 2019-2028
period.
Legislation Primarily Affecting Medicare. The following ten
bills would affect direct spending for the Medicare program.
H.R. 3528, the Every Prescription Conveyed Securely Act,
would require prescriptions for controlled substances covered
under Medicare Part D to be transmitted electronically,
starting on January 1, 2021. Based on CBO's analysis of
prescription drug spending, spending for controlled substances
is a small share of total drug spending. CBO also assumes a
small share of those prescriptions would not be filled because
they are not converted to an electronic format. Therefore, CBO
expects that enacting H.R. 3528 would reduce the number of
prescriptions filled and estimates that Medicare spending would
be reduced by $250 million over the 2019-2028 period.
H.R. 4841, the Standardizing Electronic Prior Authorization
for Safe Prescribing Act of 2018, would require health care
professionals to submit prior authorization requests
electronically, starting on January 1, 2021, for drugs covered
under Medicare Part D. Taking into account that many
prescribers already use electronic methods to submit such
requests, CBO estimates that enacting H.R. 4841 would not
significantly affect direct spending for Part D.
H.R. 5603, the Access to Telehealth Services for Opioid Use
Disorders Act, would permit the Secretary of HHS to lift
current geographic and other restrictions on coverage of
telehealth services under Medicare for treatment of substance
use disorders or co-occurring mental health disorders. Under
the bill, the Secretary of HHS would be directed to encourage
other payers to coordinate payments for opioid use disorder
treatments and to evaluate the extent to which the
demonstration reduces hospitalizations, increases the use of
medication-assisted treatments, and improves the health
outcomes of individuals with opioid use disorders during and
after the demonstration. Based on current use of Medicare
telehealth services for treatment of substance use disorders,
CBO estimates that expanding that coverage would increase
direct spending by $11 million over the 2019-2028 period.
H.R. 5605, the Advancing High Quality Treatment for Opioid
Use Disorders in Medicare Act, would establish a five-year
demonstration program to increase access to treatment for
opioid use disorder. The demonstration would provide incentive
payments and funding for care management services based on
criteria such as patient engagement, use of evidence-based
treatments, and treatment length and intensity. Under the bill,
the Secretary of HHS would be directed to encourage other
payers to coordinate payments for opioid use disorder
treatments and to evaluate the extent to which the
demonstration reduces hospitalizations, increases the use of
medication-assisted treatments, and improves the health
outcomes of individuals with opioid use disorders during and
after the demonstration. Based on historical utilization of
opioid use disorder treatments and projected spending on
incentive payments and care management fees, CBO estimates that
increased use of treatment services and the demonstration's
incentive payments would increase direct spending by $122
million over the 2019-2028 period.
H.R. 5675, a bill to amend title XVIII of the Social
Security Act to require prescription drug plan sponsors under
the Medicare program to establish drug management programs for
at-risk beneficiaries, would require Part D prescription drug
plans to provide drug management programs for Medicare
beneficiaries who are at risk for prescription drug abuse.
(Under current law, Part D plans are permitted but not required
to establish such programs as of 2019.) Based on an analysis of
the number of plans currently providing those programs, CBO
estimates that enacting H.R. 5675 would lower federal spending
by $64 million over the 2019-2028 period by reducing the number
of prescriptions filled and Medicare's payments for controlled
substances.
H.R. 5684, the Protecting Seniors From Opioid Abuse Act,
would expand medication therapy management programs under
Medicare Part D to include beneficiaries who are at risk for
prescription drug abuse. Because relatively few beneficiaries
would be affected by this bill, CBO estimates that its
enactment would not significantly affect direct spending for
Part D.
H.R. 5796, the Responsible Education Achieves Care and
Healthy Outcomes for Users' Treatment Act of 2018, would allow
the Secretary of HHS to award grants to certain organizations
that provide technical assistance and education to high-volume
prescribers of opioids. The bill would appropriate $100 million
for fiscal year 2019. Based on historical spending patterns for
similar activities, CBO estimates that implementing H.R. 5796
would cost $100 million over the 2019-2028 period.
H.R. 5798, the Opioid Screening and Chronic Pain Management
Alternatives for Seniors Act, would add an assessment of
current opioid prescriptions and screening for opioid use
disorder to the Welcome to Medicare Initial Preventive Physical
Examination. Based on historical use of the examinations and
pain management alternatives, CBO expects that enacting the
bill would increase use of pain management services and
estimates that direct spending would increase by $5 million
over the 2019-2028 period.
H.R. 5804, the Post-Surgical Injections as an Opioid
Alternative Act, would freeze the Medicare payment rate for
certain analgesic injections provided in ambulatory surgical
centers (ASCs). (For injections identified by specific billing
codes, Medicare would pay the 2016 rate, which is higher than
the current rate, during the 2020-2024 period.) Based on
current utilization in the ASC setting, CBO estimates that
enacting the legislation would increase direct spending by
about $115 million over the 2019-2028 period. (If enacted, H.R.
5804 also would affect spending subject to appropriation; see
Table 3.)
H.R. 5809, the Postoperative Opioid Prevention Act of 2018,
would create an additional payment under Medicare for nonopioid
analgesics. Under current law, certain new drugs and devices
may receive an additional payment--separate from the bundled
payment for a surgical procedure--in outpatient hospital
departments and ambulatory surgical centers. The bill would
allow nonopioid analgesics to qualify for a five-year period of
additional payments. Based on its assessment of current
spending for analgesics and on the probability of new nonopioid
analgesics coming to market, CBO estimates that H.R. 5809 would
increase direct spending by about $180 million over the 2019-
2028 period.
Legislation Primarily Affecting the Food and Drug
Administration. One bill related to the FDA would affect direct
spending.
H.R. 5333, the Over-the-Counter Monograph Safety,
Innovation, and Reform Act of 2018, would change the way that
the FDA regulates the marketing of over-the-counter (OTC)
medicines, and it would authorize that agency to grant 18
months of exclusive market protection for certain qualifying
OTC drugs, thus delaying the entry of other versions of the
same qualifying OTC product. Medicaid currently provides some
coverage for OTC medicines, but only if a medicine is the least
costly alternative in its drug class. On the basis of
stakeholder feedback, CBO expects that delaying the
availability of additional OTC versions of a drug would not
significantly affect the average net price paid by Medicaid. As
a result, CBO estimates that enacting H.R. 5333 would have a
negligible effect on the federal budget. (If enacted, H.R. 5333
also would affect spending subject to appropriation; see Table
3.)
Legislation with Revenue Effects. Two bills would affect
revenues. However, CBO estimates that one bill, H.R. 5228, the
Stop Counterfeit Drugs by Regulating and Enhancing Enforcement
Now Act, would have only a negligible effect.
H.R. 5752, the Stop Illicit Drug Importation Act of 2018,
would amend the Federal, Food, Drug, and Cosmetic Act (FDCA) to
strengthen the FDA's seizure powers and enhance its authority
to detain, refuse, seize, or destroy illegal products offered
for import. The legislation would subject more people to
debarment under the FDCA and thus increase the potential for
violations, and subsequently, the assessment of civil
penalties, which are recorded in the budget as revenues. CBO
estimates that those collections would result in an
insignificant increase in revenues. Because H.R. 5752 would
prohibit the importation of drugs that are in the process of
being scheduled, it also could reduce amounts collected in
customs duties. CBO anticipates that the result would be a
negligible decrease in revenues. With those results taken
together, CBO estimates, enacting H.R. 5752 would generate an
insignificant net increase in revenues over the 2019-2028
period.
Spending subject to appropriation
For this document, CBO has grouped bills with spending that
would be subject to appropriation into four general categories:
Bills that would have no budgetary effect,
Bills with provisions that would authorize
specified amounts to be appropriated (see Table 2),
Bills with provisions for which CBO has
estimated an authorization of appropriations (see Table
3), and
Bills with provisions that would affect
spending subject to appropriation for which CBO has not
yet completed an estimate.
No Budgetary Effect. CBO estimates that 6 of the 59 bills
would have no effect on direct spending, revenues, or spending
subject to appropriation.
H.R. 3192, the CHIP Mental Health Parity Act, would require
all Children's Health Insurance Program (CHIP) plans to cover
mental health and substance abuse treatment. In addition,
states would not be allowed to impose financial or utilization
limits on mental health treatment that are lower than limits
placed on physical health treatment. Based on information from
the Centers for Medicare and Medicaid Services, CBO estimates
that enacting the bill would have no budgetary effect because
all CHIP enrollees are already in plans that meet those
requirements.
H.R. 3331, a bill to amend title XI of the Social Security
Act to promote testing of incentive payments for behavioral
health providers for adoption and use of certified electronic
health record technology, would give the Center for Medicare
and Medicaid Innovation (CMMI) explicit authorization to test a
program offering incentive payments to behavioral health
providers that adopt and use certified electronic health record
technology. Because it is already clear to CMMI that it has
that authority, CBO estimates that enacting the legislation
would not affect federal spending.
H.R. 5202, the Ensuring Patient Access to Substance Use
Disorder Treatments Act of 2018, would clarify permission for
pharmacists to deliver controlled substances to providers under
certain circumstances. Because this provision would codify
current practice, CBO estimates that H.R. 5202 would not affect
direct spending or revenues during the 2019-2028 period.
H.R. 5685, the Medicare Opioid Safety Education Act of
2018, would require the Secretary of HHS to include information
on opioid use, pain management, and nonopioid pain management
treatments in future editions of Medicare & You, the program's
handbook for beneficiaries, starting on January 1, 2019.
Because H.R. 5685 would add information to an existing
administrative document, CBO estimates that enacting the bill
would have no budgetary effect.
H.R. 5686, the Medicare Clear Health Options in Care for
Enrollees Act of 2018, would require prescription drug plans
that provide coverage under Medicare Part D to furnish
information to beneficiaries about the risks of opioid use and
the availability of alternative treatments for pain. CBO
estimates that enacting the bill would not affect direct
spending because the required activities would not impose
significant administrative costs.
H.R. 5716, the Commit to Opioid Medical Prescriber
Accountability and Safety for Seniors Act, would require the
Secretary of HHS on an annual basis to identify high
prescribers of opioids and furnish them with information about
proper prescribing methods. Because HHS already has the
capacity to meet those requirements, CBO estimates that
enacting that provision would not impose additional
administrative costs on the agency.
Specified Authorizations. Table 2 lists the ten bills that
would authorize specified amounts to be appropriated over the
2019-2023 period. Spending from those authorized amounts would
be subject to appropriation.
TABLE 2.--ESTIMATED SPENDING SUBJECT TO APPROPRIATION FOR BILLS WITH SPECIFIED AUTHORIZATIONS
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars----
----------------------------------------------------------
2018 2019 2020 2021 2022 2023 2019-2023
----------------------------------------------------------------------------------------------------------------
INCREASES IN SPENDING SUBJECT TO APPROPRIATION
H.R. 4684, Ensuring Access to Quality Sober Living
Act:
Authorization Level.............................. 0 3 0 0 0 0 3
Estimated Outlays................................ 0 1 2 * * * 3
H.R. 5102, Substance Use Disorder Workforce Loan
Repayment Act of 2018:
Authorization Level.............................. 0 25 25 25 25 25 125
Estimated Outlays................................ 0 9 19 23 25 25 100
H.R. 5176, Preventing Overdoses While in Emergency
Rooms Act of 2018:
Authorization Level.............................. 0 50 0 0 0 0 50
Estimated Outlays................................ 0 16 26 6 2 1 50
H.R. 5197, Alternatives to Opioids (ALTO) in the
Emergency Department Act:
Authorization Level.............................. 0 10 10 10 0 0 30
Estimated Outlays................................ 0 3 8 10 7 2 30
H.R. 5261, Treatment, Education, and Community Help
to Combat Addiction Act of 2018:
Authorization Level.............................. 0 4 4 4 4 4 20
Estimated Outlays................................ 0 1 3 4 4 4 16
H.R. 5327, Comprehensive Opioid Recovery Centers Act
of 2018:
Authorization Level.............................. 0 10 10 10 10 10 50
Estimated Outlays................................ 0 3 8 10 10 10 41
H.R. 5329, Poison Center Network Enhancement Act of
2018:
Authorization Level.............................. 0 30 30 30 30 30 151
Estimated Outlays................................ 0 12 25 29 29 29 125
H.R. 5353, Eliminating Opioid-Related Infectious
Diseases Act of 2018:
Authorization Level.............................. 0 40 40 40 40 40 200
Estimated Outlays................................ 0 15 34 38 39 40 166
H.R. 5580, Surveillance and Testing of Opioids to
Prevent Fentanyl Deaths Act of 2018:
Authorization Level.............................. 30 30 30 30 30 0 120
Estimated Outlays................................ 0 11 25 29 29 19 113
H.R. 5587, Peer Support Communities of Recovery Act:
Authorization Level.............................. 0 15 15 15 15 15 75
Estimated Outlays................................ 0 5 13 14 15 15 62
----------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between zero and $500,000.
H.R. 4684, the Ensuring Access to Quality Sober Living Act,
would direct the Secretary of HHS to develop and disseminate
best practices for organizations that operate housing designed
for people recovering from substance use disorders. The bill
would authorize a total of $3 million over the 2019-2021 period
for that purpose. Based on historical spending patterns for
similar activities, CBO estimates that implementing H.R. 4684
would cost $3 million over the 2019-2023 period.
H.R. 5102, the Substance Use Disorder Workforce Loan
Repayment Act of 2018, would establish a loan repayment program
for mental health professionals who practice in areas with few
mental health providers or with high rates of death from
overdose and would authorize $25 million per year over the
2019-2028 period for that purpose. Based on historical spending
patterns for similar activities, CBO estimates that
implementing H.R. 5102 would cost $100 million over the 2019-
2023 period; the remaining amounts would be spent in years
after 2023.
H.R. 5176, the Preventing Overdoses While in Emergency
Rooms Act of 2018, would require the Secretary of HHS to
develop protocols and a grant program for health care providers
to address the needs of people who survive a drug overdose, and
it would authorize $50 million in 2019 for that purpose. Based
on historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5176 would cost $50 million
over the 2019-2023 period.
H.R. 5197, the Alternatives to Opioids (ALTO) in the
Emergency Department Act, would direct the Secretary of HHS to
carry out a demonstration program for hospitals and emergency
departments to develop alternative protocols for pain
management that limit the use of opioids and would authorize
$10 million annually in grants for fiscal years 2019 through
2021. Based on historical spending patterns for similar
programs, CBO estimates that implementing H.R. 5197 would cost
$30 million over the 2019-2023 period.
H.R. 5261, the Treatment, Education, and Community Help to
Combat Addiction Act of 2018, would direct the Secretary of
HHS to designate regional centers of excellence to improve the
training of health professionals who treat substance use
disorders. The bill would authorize $4 million annually for
grants to those programs over the 2019-2023 period. Based on
historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5261 would cost $16 million
over the 2019-2023 period; the remaining amounts would be spent
in years after 2023.
H.R. 5327, the Comprehensive Opioid Recovery Centers Act of
2018, would direct the Secretary of HHS to award grants to at
least 10 providers that offer treatment services for people
with opioid use disorder, and it would authorize $10 million
per year over the 2019-2023 period for that purpose. Based on
historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5327 would cost $41 million
over the 2019-2023 period; the remaining amounts would be spent
in years after 2023.
H.R. 5329, the Poison Center Network Enhancement Act of
2018, would reauthorize the poison control center toll-free
number, national media campaign, and grant program under the
Public Health Service Act. Among other actions, H.R. 5329 would
increase the share of poison control center funding that could
be provided by federal grants. The bill would authorize a total
of about $30 million per year over the 2019-2023 period. Based
on historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5329 would cost $125 million
over the 2019-2023 period; the remaining amounts would be spent
in years after 2023.
H.R 5353, the Eliminating Opioid Related Infectious
Diseases Act of 2018, would amend Public Health Service Act by
broadening the focus of surveillance and education programs
from preventing and treating hepatitis C virus to preventing
and treating infections associated with injection drug use. It
would authorize $40 million per year over 2019-2023 period for
that purpose. Based on historical spending patterns for similar
activities, CBO estimates that implementing H.R. 5353 would
cost $166 million over the 2019-2023 period; the remaining
amounts would be spent in years after 2023.
H.R. 5580, the Surveillance and Testing of Opioids to
Prevent Fentanyl Deaths Act of 2018, would establish a grant
program for public health laboratories that conduct testing for
fentanyl and other synthetic opioids. It also would direct the
Centers for Disease Control and Prevention to expand its drug
surveillance program, with a particular focus on collecting
data on fentanyl. The bill would authorize a total of $30
million per year over the 2018-2022 period for those
activities. Based on historical spending patterns for similar
activities, CBO estimates that implementing H.R. 5580 would
cost $113 million over the 2019-2023 period; the remaining
amounts would be spent in years after 2023.
H.R. 5587, Peer Support Communities of Recovery Act, would
direct the Secretary of HHS to award grants to nonprofit
organizations that support community-based, peer-delivered
support, including technical support for the establishment of
recovery community organizations, independent, nonprofit groups
led by people in recovery and their families. The bill would
authorize $15 million per year for the 2019-2023 period. Based
on historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5587 would cost $62 million
over the 2019-2023 period; the remaining amounts would be spent
in years after 2023.
Estimated Authorizations. Table 3 shows CBO's estimates of
the appropriations that would be necessary to implement 19 of
the bills. Spending would be subject to appropriation of those
amounts.
H.R. 449, the Synthetic Drug Awareness Act of 2018, would
require the Surgeon General to report to the Congress on the
health effects of synthetic psychoactive drugs on children
between the ages of 12 and 18. Based on spending patterns for
similar activities, CBO estimates that implementing H.R. 449
would cost approximately $1 million over the 2019-2023 period.
H.R. 4005, the Medicaid Reentry Act, would direct the
Secretary of HHS to convene a group of stakeholders to develop
and report to the Congress on best practices for addressing
issues related to health care faced by those returning from
incarceration to their communities. The bill also would require
the Secretary to issue a letter to state Medicaid directors
about relevant demonstration projects. Based on an analysis of
anticipated workload, CBO estimates that implementing H.R. 4005
would cost less than $500,000 over the 2018-2023 period.
H.R. 4275, the Empowering Pharmacists in the Fight Against
Opioid Abuse Act, would require the Secretary of HHS to develop
and disseminate materials for training pharmacists, health care
practitioners, and the public about the circumstances under
which a pharmacist may decline to fill a prescription. Based on
historical spending patterns for similar activities, CBO
estimates that costs to the federal government for the
development and distribution of those materials would not be
significant.
TABLE 3.--ESTIMATED SPENDING SUBJECT TO APPROPRIATION FOR BILLS WITH ESTIMATED AUTHORIZATIONS
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-------------------------------------------------------------
2018 2019 2020 2021 2022 2023 2019-2023
----------------------------------------------------------------------------------------------------------------
INCREASES IN SPENDING SUBJECT TO APPROPRIATION
H.R. 449, Synthetic Drug Awareness Act of 2018:
Estimated Authorization Level................. 0 * * * 0 0 1
Estimated Outlays............................. 0 * * * 0 0 1
H.R. 4005, Medicaid Reentry Act:
Estimated Authorization Level................. * * 0 0 0 0 *
Estimated Outlays............................. * * 0 0 0 0 *
H.R. 4275, Empowering Pharmacists in the Fight
Against Opioid Abuse Act:
Estimated Authorization Level................. 0 * * * * * *
Estimated Outlays............................. 0 * * * * * *
H.R. 5009, Jessie's Law:
Estimated Authorization Level................. 0 * * * * * *
Estimated Outlays............................. 0 * * * * * *
H.R. 5041, Safe Disposal of Unused Medication Act:
Estimated Authorization Level................. 0 * * * * * *
Estimated Outlays............................. 0 * * * * * *
H.R. 5272, Reinforcing Evidence-Based Standards
Under Law in Treating Substance Abuse Act of
2018:
Estimated Authorization Level................. 0 1 1 1 1 1 4
Estimated Outlays............................. 0 1 1 1 1 1 4
H.R. 5333, Over-the-Counter Monograph Safety,
Innovation, and Reform Act of 2018:a
Food and Drug Administration:
Collections from fees:
Estimated Authorization Level......... 0 -22 -22 -26 -35 -42 -147
Estimated Outlays..................... 0 -22 -22 -26 -35 -42 -147
Spending of fees:
Estimated Authorization Level......... 0 22 22 26 35 42 147
Estimated Outlays..................... 0 6 17 30 44 41 137
Net effect on FDA:
Estimated Authorization Level......... 0 0 0 0 0 0 0
Estimated Outlays..................... 0 -17 -6 4 9 * -10
Government Accountability Office:
Estimated Authorization Level............. 0 0 0 0 0 * *
Estimated Outlays......................... 0 0 0 0 0 * *
Total, H.R. 5333:
Estimated Authorization Level............. 0 0 0 0 0 * *
Estimated Outlays......................... 0 -17 -6 4 9 * -10
H.R. 5473, Better Pain Management Through Better
Data Act of 2018:
Estimated Authorization Level................. 0 * * * * 0 1
Estimated Outlays............................. 0 * * * * * 1
H.R. 5483, Special Registration for Telemedicine
Clarification Act of 2018:
Estimated Authorization Level................. 0 * * * * * *
Estimated Outlays............................. 0 * * * * * *
H.R. 5554, Animal Drug and Animal Generic Drug
User Fee Amendments of 2018:
Collections from fees:
Animal drug fees.......................... 0 -30 -31 -32 -33 -34 -159
Generic animal drug fees.................. 0 -18 -19 -19 -20 -21 -97
Total, Estimated Authorization Level.. 0 -49 -50 -51 -53 -55 -257
Total, Estimated Outlays.............. 0 -49 -50 -51 -53 -55 -257
Spending of fees:
Animal drug fees.......................... 0 30 31 32 33 34 159
Generic animal drug fees.................. 0 18 19 19 20 21 97
Total, Estimated Authorization Level.. 0 49 50 51 53 55 257
Total, Estimated Outlays.............. 0 39 47 51 52 54 243
Net changes in fees:
Estimated Authorization Level............. 0 0 0 0 0 0 0
Estimated Outlays......................... 0 -10 -3 * * * -14
Other effects:
Estimated Authorization Level............. 0 3 1 1 1 1 6
Estimated Outlays......................... 0 2 1 1 1 1 6
Total, H.R. 5554:
Estimated Authorization Level............. 0 3 1 1 1 1 6
Estimated Outlays......................... 0 -8 -2 1 * * -8
H.R. 5582, Abuse Deterrent Access Act of 2018:
Estimated Authorization Level................. 0 0 * 0 0 0 *
Estimated Outlays............................. 0 0 * 0 0 0 *
H.R. 5590, Opioid Addiction Action Plan Act:
Estimated Authorization Level................. * * * * * * 2
Estimated Outlays............................. * * * * * * 2
H.R. 5687, Securing Opioids and Unused Narcotics
with Deliberate Disposal and Packaging Act of
2018:
Estimated Authorization Level................. 0 * * * * * *
Estimated Outlays............................. 0 * * * * * *
H.R. 5715, Strengthening Partnerships to Prevent
Opioid Abuse Act:
Estimated Authorization Level................. 0 2 2 2 2 2 9
Estimated Outlays............................. 0 2 2 2 2 2 9
H.R. 5789, a bill to require the Secretary of
Health and Human Services to issue guidance to
improve care for infants with neonatal abstinence
syndrome and their mothers, and to require the
Comptroller General of the United States to
conduct a study on gaps in Medicaid coverage for
pregnant and postpartum women with substance use
disorder:
Estimated Authorization Level................. 0 2 0 0 0 0 2
Estimated Outlays............................. 0 2 0 0 0 0 2
H.R. 5795, Overdose Prevention and Patient Safety
Act:
Estimated Authorization Level................. 0 1 0 0 0 0 1
Estimated Outlays............................. 0 1 0 0 0 0 1
H.R. 5800, Medicaid IMD ADDITIONAL INFO Act:
Estimated Authorization Level................. 0 1 0 0 0 0 1
Estimated Outlays............................. 0 * * 0 0 0 1
H.R. 5804, Post-Surgical Injections as an Opioid
Alternative Act:a
Estimated Authorization Level................. 0 0 0 0 1 1 1
Estimated Outlays............................. 0 0 0 0 1 1 1
H.R. 5811, a bill to amend the Federal Food, Drug,
and Cosmetic Act with respect to postapproval
study requirements for certain controlled
substances, and for other purposes:
Estimated Authorization Level................. 0 * * * * * *
Estimated Outlays............................. 0 * * * * * *
----------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between -$500,000 and $500,000.
aThis bill also would affect mandatory spending (see Table 1).
H.R. 5009, Jessie's Law, would require HHS, in
collaboration with outside experts, to develop best practices
for displaying information about opioid use disorder in a
patient's medical record. HHS also would be required to develop
and disseminate written materials annually to health care
providers about what disclosures could be made while still
complying with federal laws that govern health care privacy.
Based on spending patterns for similar activities, CBO
estimates that implementing H.R. 5009 would have an
insignificant effect on spending over the 2019-2023 period.
H.R. 5041, the Safe Disposal of Unused Medication Act,
would require hospice programs to have written policies and
procedures for the disposal of controlled substances after a
patient's death. Certain licensed employees of hospice programs
would be permitted to assist in the disposal of controlled
substances that were lawfully dispensed. Using information from
the Department of Justice (DOJ), CBO estimates that
implementing the bill would cost less than $500,000 over the
2019-2023 period.
H.R. 5272, the Reinforcing Evidence-Based Standards Under
Law in Treating Substance Abuse Act of 2018, would require the
newly established National Mental Health and Substance Use
Policy Laboratory to issue guidance to applicants for SAMHSA
grants that support evidence-based practices. Using information
from HHS about the historical cost of similar activities, CBO
estimates that enacting this bill would cost approximately $4
million over the 2019-2023 period.
H.R. 5333, the Over-the-Counter Monograph Safety,
Innovation, and Reform Act of 2018, would change the FDA's
oversight of the commercial marketing of OTC medicines and
authorize the collection and spending of fees through 2023 to
cover the costs of expediting the FDA's administrative
procedures for certain regulatory activities relating to OTC
products. Under H.R. 5333, CBO estimates, the FDA would assess
about $147 million in fees over the 2019-2023 period that could
be collected and made available for obligation only to the
extent and in the amounts provided in advance in appropriation
acts. Because the FDA could spend those fees, CBO estimates
that the estimated budget authority for collections and
spending would offset each other exactly in each year, although
CBO expects that spending initially would lag behind
collections. Assuming appropriation action consistent with the
bill, CBO estimates that implementing H.R. 5333 would reduce
net discretionary outlays by $10 million over the 2019-2023
period, primarily because of that lag. The bill also would
require the Government Accountability Office to study exclusive
market protections for certain qualifying OTC drugs authorized
by the bill--a provision that CBO estimates would cost less
than $500,000. (If enacted, H.R. 5333 also would affect
mandatory spending; see Table 1.)
H.R. 5473, the Better Pain Management Through Better Data
Act of 2018, would require that the FDA conduct a public
meeting and issue guidance to industry addressing data
collection and labeling for medical products that reduce pain
while enabling the reduction, replacement, or avoidance of oral
opioids. Using information from the agency, CBO estimates that
implementing H.R. 5473 would cost about $1 million over the
2019-2023 period.
H.R. 5483, the Special Registration for Telemedicine
Clarification Act of 2018, would direct DOJ, within one year of
the bill's enactment, to issue regulations concerning the
practice of telemedicine (for remote diagnosis and treatment of
patients). Using information from DOJ, CBO estimates that
implementing the bill would cost less than $500,000 over the
2019-2023 period.
H.R. 5554, the Animal Drug and Animal Generic Drug User Fee
Amendments of 2018, would authorize the FDA to collect and
spend fees to cover the cost of expedited approval for the
development and marketing of certain drugs for use in animals.
The legislation would extend through fiscal year 2023, and make
several changes to, the FDA's existing approval processes and
fee programs for brand-name and generic veterinary drugs, which
expire at the end of fiscal year 2018. CBO estimates that
implementing H.R. 5554 would reduce net discretionary outlays
by $8 million over the 2019-2023 period, primarily because the
spending of fees lags somewhat behind their collection.
Fees authorized under the bill would supplement funds
appropriated to cover the FDA's cost of reviewing certain
applications and investigational submissions for brand-name and
generic drugs for use in animals. Those fees could be collected
and made available for obligation only to the extent and in the
amounts provided in advance in appropriation acts. Under H.R.
5554, CBO estimates, the FDA would assess about $257 million in
fees over the 2019-2023 period. Because the FDA could spend
those funds, CBO estimates that budget authority for
collections and spending would offset each other exactly in
each year. CBO estimates that the delay between collecting and
spending fees under the reauthorized programs would reduce net
discretionary outlays by $14 million over the 2019-2023 period,
assuming appropriation actions consistent with the bill.
Enacting H.R. 5554 would increase the FDA's workload
because the legislation would expand eligibility for
conditional approval for certain drugs. The agency's
administrative costs also would increase because of regulatory
activities required by a provision concerning petitions for
additives intended for use in animal food. H.R. 5554 also would
require the FDA to publish guidance or produce regulations on a
range of topics, transmit a report to the Congress, and hold
public meetings. CBO expects that the costs associated with
those activities would not be covered by fees, and it estimates
that implementing such provisions would cost $6 million over
the 2019-2023 period.
H.R. 5582, the Abuse Deterrent Access Act of 2018, would
require the Secretary of HHS to report to the Congress on
existing barriers to access to ``abuse-deterrent opioid
formulations'' by Medicare Part C and D beneficiaries. Such
formulations make the drugs more difficult to dissolve for
injection, for example, and thus can impede their abuse.
Assuming the availability of appropriated funds and based on
historical spending patterns for similar activities, CBO
estimates that implementing the legislation would cost less
than $500,000 over the 2019-2023 period.
H.R. 5590, the Opioid Addiction Action Plan Act, would
require the Secretary of HHS to develop an action plan by
January 1, 2019, for increasing access to medication-assisted
treatment among Medicare and Medicaid enrollees. The bill also
would require HHS to convene a stakeholder meeting and issue a
request for information within three months of enactment, and
to submit a report to the Congress by June 1, 2019. Based on
historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5590 would cost approximately
$2 million over the 2019-2023 period.
H.R. 5687, the Securing Opioids and Unused Narcotics with
Deliberate Disposal and Packaging Act of 2018, would permit the
FDA to require certain packaging and disposal technologies,
controls, or measures to mitigate the risk of abuse and misuse
of drugs. Based on information from the FDA, CBO estimates that
implementing H.R. 5687 would not significantly affect spending
over the 2019-2023 period. This bill would also require that
the GAO study the effectiveness and use of packaging
technologies for controlled substances--a provision that CBO
estimates would cost less than $500,000.
H.R. 5715, the Strengthening Partnerships to Prevent Opioid
Abuse Act, would require the Secretary of HHS to establish a
secure Internet portal to allow HHS, Medicare Advantage plans,
and Medicare Part D plans to exchange information about fraud,
waste, and abuse among providers and suppliers no later than
two years after enactment. H.R. 5715 also would require
organizations with Medicare Advantage contracts to submit
information on investigations related to providers suspected of
prescribing large volumes of opioids through a process
established by the Secretary no later than January 2021. Based
on historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5715 would cost approximately
$9 million over the 2019-2023 period.
H.R. 5789, a bill to require the Secretary of Health and
Human Services to issue guidance to improve care for infants
with neonatal abstinence syndrome and their mothers, and to
require the Comptroller General of the United States to conduct
a study on gaps in Medicaid coverage for pregnant and
postpartum women with substance use disorder, would direct the
Secretary of HHS to issue guidance to states on best practices
under Medicaid and CHIP for treating infants with neonatal
abstinence syndrome. H.R. 5789 also would direct the Government
Accountability Office to study Medicaid coverage for pregnant
and postpartum women with substance use disorders. Based on
inforation from HHS and historical spending patterns for
similar activities, CBO estimates that enacting H.R. 5789 would
cost approximately $2 million over the 2019-2023 period.
H.R. 5795, the Overdose Prevention and Patient Safety Act,
would amend the Public Health Service Act so that requirements
pertaining to the confidentiality and disclosure of medical
records relating to substance use disorders align with the
provisions of the Health Insurance Portability and
Accountability Act of 1996. The bill would require the Office
of the Secretary of HHS to issue regulations prohibiting
discrimination based on data disclosed from such medical
records, to issue regulations requiring covered entities to
provide written notice of privacy practices, and to develop
model training programs and materials for health care providers
and patients and their families. Based on spending patterns for
similar activities, CBO estimates that implementing H.R. 5795
would cost approximately $1 million over the 2019-2023 period.
H.R. 5800, Medicaid IMD ADDITIONAL INFO Act, would direct
the Medicaid and CHIP Payment and Access Commission to study
institutions for mental diseases in a representative sample of
states. Based on information from the commission about the cost
of similar work, CBO estimates that implementing H.R. 5800
would cost about $1 million over the 2019-2023 period.
H.R. 5804, the Post-Surgical Injections as an Opioid
Alternative Act, would freeze the Medicare payment rate for
certain analgesic injections provided in ambulatory surgical
centers. The bill also would mandate two studies of Medicare
coding and payments arising from enactment of this legislation.
Based on the cost of similar activities, CBO estimates that
those reports would cost $1 million over the 2019-2023 period.
(If enacted, H.R. 5804 also would affect mandatory spending;
see Table 1.)
H.R. 5811, a bill to amend the Federal Food, Drug, and
Cosmetic Act with respect to postapproval study requirements
for certain controlled substances, and for other purposes,
would allow the FDA to require that pharmaceutical
manufacturers study certain drugs after they are approved to
assess any potential reduction in those drugs' effectiveness
for the conditions of use prescribed, recommended, or suggested
in labeling. CBO anticipates that implementing H.R. 5811 would
not significantly affect the FDA's costs over the 2019-2023
period.
Other Authorizations. The following nine bills would
increase authorization levels, but CBO has not completed
estimates of amounts. All authorizations would be subject to
future appropriation action.
H.R. 4284, Indexing Narcotics, Fentanyl, and
Opioids Act of 2017
H.R. 5002, Advancing Cutting Edge Research
Act
H.R. 5228, Stop Counterfeit Drugs by
Regulating and Enhancing Enforcement Now Act (see Table
1 for an estimate of the revenue effects of H.R. 5228)
H.R. 5752, Stop Illicit Drug Importation Act
of 2018 (see Table 1 for an estimate of the revenue
effects of H.R. 5752)
H.R. 5799, Medicaid DRUG Improvement Act
(see Table 1 for an estimate of the direct spending
effects of H.R. 5799)
H.R. 5801, Medicaid Providers and
Pharmacists Are Required to Note Experiences in Record
Systems to Help In-Need Patients (PARTNERSHIP) Act (see
Table 1 for an estimate of the direct spending effects
of H.R. 5801)
H.R. 5806, 21st Century Tools for Pain and
Addiction Treatments Act
H.R. 5808, Medicaid Pharmaceutical Home Act
of 2018 (see Table 1 for an estimate of the direct
spending effects of H.R. 5808)
H.R. 5812, Creating Opportunities that
Necessitate New and Enhanced Connections That Improve
Opioid Navigation Strategies Act (CONNECTIONS) Act
Pay-As-You-Go considerations: The Statutory Pay-As-You-Go
Act of 2010 establishes budget-reporting and enforcement
procedures for legislation affecting direct spending or
revenues. Twenty-two of the bills discussed in this document
contain direct spending or revenues and are subject to pay-as-
you-go procedures. Details about the amount of direct spending
and revenues in those bills can be found in Table 1.
Increase in long-term direct spending and deficits: CBO
estimates that enacting H.R. 4998, the Health Insurance for
Former Foster Youth Act, would increase net direct spending by
more than $2.5 billion and on-budget deficits by more than $5
billion in at least one of the four consecutive 10-year periods
beginning in 2029.
CBO estimates that none of the remaining 58 bills included
in this estimate would increase net direct spending by more
than $2.5 billion or on-budget deficits by more than $5 billion
in any of the four consecutive 10-year periods beginning in
2029.
Mandates: One of the 59 bills included in this document,
H.R. 5795, would impose both intergovernmental and private-
sector mandates as defined in UMRA. CBO estimates that the
costs of that bill's mandates on public and private entities
would fall below UMRA's thresholds ($80 million and $160
million, respectively, for public- and private-sector entities
in 2018, adjusted annually for inflation).
In addition, five bills would impose private-sector
mandates as defined in UMRA. CBO estimates that the costs of
the mandates in three of those bills (H.R. 5333, H.R. 5554, and
H.R. 5811) would fall below the UMRA threshold. Because CBO
does not know how federal agencies would implement new
authority granted in the other two of those five bills, H.R.
5228 and 5687, CBO cannot determine whether the costs of their
mandates would exceed the threshold.
For large entitlement grant programs, including Medicaid
and CHIP, UMRA defines an increase in the stringency of
conditions on states or localities as an intergovernmental
mandate if the affected governments lack authority to offset
those costs while continuing to provide required services.
Because states possess significant flexibility to alter their
responsibilities within Medicaid and CHIP, the requirements
imposed by various bills in the markup on state administration
of those programs would not constitute mandates as defined in
UMRA.
Mandates Affecting Public and Private Entities
H.R. 5795, the Overdose Prevention and Patient Safety Act,
would impose intergovernmental and private-sector mandates by
requiring entities that provide treatment for substance use
disorders to notify patients of their privacy rights and also
to notify patients in the event that the confidentiality of
their records is breached. In certain circumstances, H.R. 5795
also would prohibit public and private entities from denying
entry to treatment on the basis of information in patient
health records. Those requirements would either supplant or
narrowly expand responsibilities under existing law, and
compliance with them would not impose significant additional
costs. CBO estimates that the costs of the mandates would fall
below the annual thresholds established in UMRA.
Mandates Affecting Private Entities
Five bills included in this document would impose private-
sector mandates:
H.R. 5228, the Stop Counterfeit Drugs by Regulating and
Enhancing Enforcement Now Act, would require drug distributors
to cease distributing any drug that the Secretary of HHS
determines might present an imminent or substantial hazard to
public health. CBO cannot determine what drugs could be subject
to such an order nor can it determine how private entities
would respond. Consequently, CBO cannot determine whether the
aggregate cost of the mandate would exceed the annual threshold
for private-sector mandates.
H.R. 5333, the Over-the-Counter Monograph Safety,
Innovation, and Reform Act of 2018, would require developers
and manufacturers of OTC drugs to pay certain fees to the FDA.
CBO estimates that about $30 million would be collected each
year, on average, for a total of $147 million over the 2019-
2023 period. Those amounts would not exceed the annual
threshold for private-sector mandates in any year during that
period.
H.R. 5554, the Animal Drug and Animal Generic Drug User Fee
Amendments of 2018, would require developers and manufacturers
of brand-name and generic veterinary drugs to pay application,
product, establishment, and sponsor fees to the FDA. CBO
estimates that about $51 million would be collected annually,
on average, for a total of $257 million over the 2019-2023
period. Those amounts would not exceed the annual threshold for
private-sector mandates in any year during that period.
H.R. 5687, the Securing Opioids and Unused Narcotics with
Deliberate Disposal and Packaging Act of 2018, would permit the
Secretary of HHS to require drug developers and manufacturers
to implement new packaging and disposal technology for certain
drugs. Based on information from the agency, CBO expects that
the Secretary would use the new regulatory authority provided
in the bill; however, it is uncertain how or when those
requirements would be implemented. Consequently, CBO cannot
determine whether the aggregate cost of the mandate would
exceed the annual threshold for private entities.
H.R. 5811, a bill to amend the Federal Food, Drug, and
Cosmetic Act with respect to postapproval study requirements
for certain controlled substances, and for other purposes,
would expand an existing mandate that requires drug developers
to conduct postapproval studies or clinical trials for certain
drugs. Under current law, in certain instances, the FDA can
require studies or clinical trials after a drug has been
approved. H.R. 5811 would permit the FDA to use that authority
if the reduction in a drug's effectiveness meant that its
benefits no longer outweighed its costs. CBO estimates that the
incremental cost of the mandate would fall below the annual
threshold established in UMRA because of the small number of
drugs affected and the narrow expansion of the authority that
exists under current law.
None of the remaining 53 bills included in this document
would impose an intergovernmental or private-sector mandate.
Previous CBO estimate: On June 6, 2018, CBO issued an
estimate for seven opioid-related bills ordered reported by the
House Committee on Ways and Means on May 16, 2018. Two of those
bills contain provisions that are identical or similar to the
legislation ordered reported by the Committee on Energy and
Commerce, and for those provisions, CBO's estimates are the
same.
In particular, five bills listed in this estimate contain
provisions that are identical or similar to those in several
sections of H.R. 5773, the Preventing Addiction for Susceptible
Seniors Act of 2018:
H.R. 5675, which would require prescription
drug plans to implement drug management programs, is
identical to section 2 of H.R. 5773.
H.R. 4841, regarding electronic prior
authorization for prescriptions under Medicare's Part
D, is similar to section 3 of H.R. 5773.
H.R. 5715, which would mandate the creation
of a new Internet portal to allow various stakeholders
to exchange information, is identical to section 4 of
H.R. 5773.
H.R. 5684, which would expand medication
therapy management, is the same as section 5 of H.R.
5773.
H.R. 5716, regarding prescriber
notification, is identical to section 6 of H.R. 5773.
In addition, in this estimate, a provision related to
Medicare beneficiary education in H.R. 5686, the Medicare Clear
Health Options in Care for Enrollees Act of 2018, is the same
as a provision in section 2 of H.R. 5775, the Providing
Reliable Options for Patients and Educational Resources Act of
2018, in CBO's estimate for the Committee on Ways and Means.
Estimate prepared by: Federal Costs: Rebecca Yip (Centers
for Disease Control and Prevention), Mark Grabowicz (Drug
Enforcement Agency), Julia Christensen, Ellen Werble (Food and
Drug Administration), Emily King, Andrea Noda, Lisa Ramirez-
Branum, Robert Stewart (Medicaid and Children's Health
Insurance Program), Philippa Haven, Lara Robillard, Colin Yee,
Rebecca Yip (Medicare), Philippa Haven (National Institutes of
Health), Alice Burns, Andrea Noda (Office of the Secretary of
the Department of Health and Human Services), Philippa Haven,
Lori Housman, Emily King (Substance Abuse and Mental Health
Services Administration, Health Resources and Services
Administration); Federal Revenues: Jacob Fabian, Peter Huether,
and Cecilia Pastrone; Fact Checking: Zachary Byrum and Kate
Kelly; Mandates: Andrew Laughlin.
Estimate reviewed by: Tom Bradley, Chief, Health Systems
and Medicare Cost Estimates Unit; Chad M. Chirico, Chief, Low-
Income Health Programs and Prescription Drugs Cost Estimates
Unit; Sarah Masi, Special Assistant for Health; Susan Willie,
Chief, Mandates Unit; Leo Lex, Deputy Assistant Director for
Budget Analysis; Theresa A. Gullo, Assistant Director for
Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Statement of General Performance Goals and Objectives
Pursuant to clause 3(c)(4) of rule XIII, the general
performance goal or objective of this legislation is to direct
the Centers for Medicare and Medicaid Services to require e-
prescribing for coverage of prescribed controlled substances
under the Medicare Part D program.
Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 3528 is known to be duplicative of another Federal
program, including any program that was included in a report to
Congress pursuant to section 21 of Public Law 111-139 or the
most recent Catalog of Federal Domestic Assistance.
Committee Cost Estimate
Pursuant to clause 3(d)(1) of rule XIII, the Committee
adopts as its own the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974.
Earmark, Limited Tax Benefits, and Limited Tariff Benefits
Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the
Committee finds that H.R. 3528 contains no earmarks, limited
tax benefits, or limited tariff benefits.
Disclosure of Directed Rule Makings
Pursuant to section 3(i) of H. Res. 5, the following
directed rule makings are contained in H.R. 3528:
Section 2(a)(B): The Secretary shall,
pursuant to rulemaking, specify circumstances with
respect to which the Secretary may waive the
requirement under subparagraph (A), with respect to a
covered part D drug.
Section 2(a)(D): The Secretary shall,
pursuant to rulemaking, have authority to enforce and
specify appropriate penalties for noncompliance with
the requirement under subparagraph (A).
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 provide that the Act may be cited as the ``Every
Prescription Conveyed Securely Act.''
Section 2. Requiring E-prescribing for coverage of covered Part D
controlled substances
Section requires prescriptions for a schedule II, III, IV,
or V controlled substance covered under a part D prescription
drug plan or MA-PD plan to be transmitted in accordance with an
electronic prescription drug program by January 1, 2021. The
Secretary may waive this requirement in certain defined cases,
such as reasonable technological limitations.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (new matter is
printed in italic and existing law in which no change is
proposed is shown in roman):
SOCIAL SECURITY ACT
* * * * * * *
TITLE XVIII--HEALTH INSURANCE FOR THE AGED AND DISABLED
* * * * * * *
Part D--Voluntary Prescription Drug Benefit Program
* * * * * * *
Subpart 1--Part D Eligible Individuals and Prescription Drug Benefits
* * * * * * *
beneficiary protections for qualified prescription drug coverage
Sec. 1860D-4. (a) Dissemination of Information.--
(1) General information.--
(A) Application of ma information.--A PDP
sponsor shall disclose, in a clear, accurate,
and standardized form to each enrollee with a
prescription drug plan offered by the sponsor
under this part at the time of enrollment and
at least annually thereafter, the information
described in section 1852(c)(1) relating to
such plan, insofar as the Secretary determines
appropriate with respect to benefits provided
under this part, and including the information
described in subparagraph (B).
(B) Drug specific information.--The
information described in this subparagraph is
information concerning the following:
(i) Access to specific covered part D
drugs, including access through
pharmacy networks.
(ii) How any formulary (including any
tiered formulary structure) used by the
sponsor functions, including a
description of how a part D eligible
individual may obtain information on
the formulary consistent with paragraph
(3).
(iii) Beneficiary cost-sharing
requirements and how a part D eligible
individual may obtain information on
such requirements, including tiered or
other copayment level applicable to
each drug (or class of drugs),
consistent with paragraph (3).
(iv) The medication therapy
management program required under
subsection (c).
(v) The drug management program for
at-risk beneficiaries under subsection
(c)(5).
(2) Disclosure upon request of general coverage,
utilization, and grievance information.--Upon request
of a part D eligible individual who is eligible to
enroll in a prescription drug plan, the PDP sponsor
offering such plan shall provide information similar
(as determined by the Secretary) to the information
described in subparagraphs (A), (B), and (C) of section
1852(c)(2) to such individual.
(3) Provision of specific information.--
(A) Response to beneficiary questions.--Each
PDP sponsor offering a prescription drug plan
shall have a mechanism for providing specific
information on a timely basis to enrollees upon
request. Such mechanism shall include access to
information through the use of a toll-free
telephone number and, upon request, the
provision of such information in writing.
(B) Availability of information on changes in
formulary through the internet.--A PDP sponsor
offering a prescription drug plan shall make
available on a timely basis through an Internet
website information on specific changes in the
formulary under the plan (including changes to
tiered or preferred status of covered part D
drugs).
(4) Claims information.--A PDP sponsor offering a
prescription drug plan must furnish to each enrollee in
a form easily understandable to such enrollees--
(A) an explanation of benefits (in accordance
with section 1806(a) or in a comparable
manner); and
(B) when prescription drug benefits are
provided under this part, a notice of the
benefits in relation to--
(i) the initial coverage limit for
the current year; and
(ii) the annual out-of-pocket
threshold for the current year.
Notices under subparagraph (B) need not be
provided more often than as specified by the
Secretary and notices under subparagraph
(B)(ii) shall take into account the application
of section 1860D-2(b)(4)(C) to the extent
practicable, as specified by the Secretary.
(b) Access to Covered Part D Drugs.--
(1) Assuring pharmacy access.--
(A) Participation of any willing pharmacy.--A
prescription drug plan shall permit the
participation of any pharmacy that meets the
terms and conditions under the plan.
(B) Discounts allowed for network
pharmacies.--For covered part D drugs dispensed
through in-network pharmacies, a prescription
drug plan may, notwithstanding subparagraph
(A), reduce coinsurance or copayments for part
D eligible individuals enrolled in the plan
below the level otherwise required. In no case
shall such a reduction result in an increase in
payments made by the Secretary under section
1860D-15 to a plan.
(C) Convenient access for network
pharmacies.--
(i) In general.--The PDP sponsor of
the prescription drug plan shall secure
the participation in its network of a
sufficient number of pharmacies that
dispense (other than by mail order)
drugs directly to patients to ensure
convenient access (consistent with
rules established by the Secretary).
(ii) Application of tricare
standards.--The Secretary shall
establish rules for convenient access
to in-network pharmacies under this
subparagraph that are no less favorable
to enrollees than the rules for
convenient access to pharmacies
included in the statement of work of
solicitation (#MDA906-03-R-0002) of the
Department of Defense under the TRICARE
Retail Pharmacy (TRRx) as of March 13,
2003.
(iii) Adequate emergency access.--
Such rules shall include adequate
emergency access for enrollees.
(iv) Convenient access in long-term
care facilities.--Such rules may
include standards with respect to
access for enrollees who are residing
in long-term care facilities and for
pharmacies operated by the Indian
Health Service, Indian tribes and
tribal organizations, and urban Indian
organizations (as defined in section 4
of the Indian Health Care Improvement
Act).
(D) Level playing field.--Such a sponsor
shall permit enrollees to receive benefits
(which may include a 90-day supply of drugs or
biologicals) through a pharmacy (other than a
mail order pharmacy), with any differential in
charge paid by such enrollees.
(E) Not required to accept insurance risk.--
The terms and conditions under subparagraph (A)
may not require participating pharmacies to
accept insurance risk as a condition of
participation.
(2) Use of standardized technology.--
(A) In general.--The PDP sponsor of a
prescription drug plan shall issue (and
reissue, as appropriate) such a card (or other
technology) that may be used by an enrollee to
assure access to negotiated prices under
section 1860D-2(d).
(B) Standards.--
(i) In general.--The Secretary shall
provide for the development, adoption,
or recognition of standards relating to
a standardized format for the card or
other technology required under
subparagraph (A). Such standards shall
be compatible with part C of title XI
and may be based on standards developed
by an appropriate standard setting
organization.
(ii) Consultation.--In developing the
standards under clause (i), the
Secretary shall consult with the
National Council for Prescription Drug
Programs and other standard setting
organizations determined appropriate by
the Secretary.
(iii) Implementation.--The Secretary
shall develop, adopt, or recognize the
standards under clause (i) by such date
as the Secretary determines shall be
sufficient to ensure that PDP sponsors
utilize such standards beginning
January 1, 2006.
(3) Requirements on development and application of
formularies.--If a PDP sponsor of a prescription drug
plan uses a formulary (including the use of tiered
cost-sharing), the following requirements must be met:
(A) Development and revision by a pharmacy
and therapeutic (p&t;) committee.--
(i) In general.--The formulary must
be developed and reviewed by a pharmacy
and therapeutic committee. A majority
of the members of such committee shall
consist of individuals who are
practicing physicians or practicing
pharmacists (or both).
(ii) Inclusion of independent
experts.--Such committee shall include
at least one practicing physician and
at least one practicing pharmacist,
each of whom--
(I) is independent and free
of conflict with respect to the
sponsor and plan; and
(II) has expertise in the
care of elderly or disabled
persons.
(B) Formulary development.--In developing and
reviewing the formulary, the committee shall--
(i) base clinical decisions on the
strength of scientific evidence and
standards of practice, including
assessing peer-reviewed medical
literature, such as randomized clinical
trials, pharmacoeconomic studies,
outcomes research data, and on such
other information as the committee
determines to be appropriate; and
(ii) take into account whether
including in the formulary (or in a
tier in such formulary) particular
covered part D drugs has therapeutic
advantages in terms of safety and
efficacy.
(C) Inclusion of drugs in all therapeutic
categories and classes.--
(i) In general.--Subject to
subparagraph (G), the formulary must
include drugs within each therapeutic
category and class of covered part D
drugs, although not necessarily all
drugs within such categories and
classes.
(ii) Model guidelines.--The Secretary
shall request the United States
Pharmacopeia to develop, in
consultation with pharmaceutical
benefit managers and other interested
parties, a list of categories and
classes that may be used by
prescription drug plans under this
paragraph and to revise such
classification from time to time to
reflect changes in therapeutic uses of
covered part D drugs and the additions
of new covered part D drugs.
(iii) Limitation on changes in
therapeutic classification.--The PDP
sponsor of a prescription drug plan may
not change the therapeutic categories
and classes in a formulary other than
at the beginning of each plan year
except as the Secretary may permit to
take into account new therapeutic uses
and newly approved covered part D
drugs.
(D) Provider and patient education.--The PDP
sponsor shall establish policies and procedures
to educate and inform health care providers and
enrollees concerning the formulary.
(E) Notice before removing drug from
formulary or changing preferred or tier status
of drug.--Any removal of a covered part D drug
from a formulary and any change in the
preferred or tiered cost-sharing status of such
a drug shall take effect only after appropriate
notice is made available (such as under
subsection (a)(3)) to the Secretary, affected
enrollees, physicians, pharmacies, and
pharmacists.
(F) Periodic evaluation of protocols.--In
connection with the formulary, the sponsor of a
prescription drug plan shall provide for the
periodic evaluation and analysis of treatment
protocols and procedures.
(G) Required inclusion of drugs in certain
categories and classes.--
(i) Formulary requirements.--
(I) In general.--Subject to
subclause (II), a PDP sponsor
offering a prescription drug
plan shall be required to
include all covered part D
drugs in the categories and
classes identified by the
Secretary under clause (ii)(I).
(II) Exceptions.--The
Secretary may establish
exceptions that permit a PDP
sponsor offering a prescription
drug plan to exclude from its
formulary a particular covered
part D drug in a category or
class that is otherwise
required to be included in the
formulary under subclause (I)
(or to otherwise limit access
to such a drug, including
through prior authorization or
utilization management).
(ii) Identification of drugs in
certain categories and classes.--
(I) In general.--Subject to
clause (iv), the Secretary
shall identify, as appropriate,
categories and classes of drugs
for which the Secretary
determines are of clinical
concern.
(II) Criteria.--The Secretary
shall use criteria established
by the Secretary in making any
determination under subclause
(I).
(iii) Implementation.--The Secretary
shall establish the criteria under
clause (ii)(II) and any exceptions
under clause (i)(II) through the
promulgation of a regulation which
includes a public notice and comment
period.
(iv) Requirement for certain
categories and classes until criteria
established.--Until such time as the
Secretary establishes the criteria
under clause (ii)(II) the following
categories and classes of drugs shall
be identified under clause (ii)(I):
(I) Anticonvulsants.
(II) Antidepressants.
(III) Antineoplastics.
(IV) Antipsychotics.
(V) Antiretrovirals.
(VI) Immunosuppressants for
the treatment of transplant
rejection.
(H) Use of single, uniform exceptions and
appeals process.--Notwithstanding any other
provision of this part, each PDP sponsor of a
prescription drug plan shall--
(i) use a single, uniform exceptions
and appeals process (including, to the
extent the Secretary determines
feasible, a single, uniform model form
for use under such process) with
respect to the determination of
prescription drug coverage for an
enrollee under the plan; and
(ii) provide instant access to such
process by enrollees through a toll-
free telephone number and an Internet
website.
(c) Cost and Utilization Management; Quality Assurance;
Medication Therapy Management Program.--
(1) In general.--The PDP sponsor shall have in place,
directly or through appropriate arrangements, with
respect to covered part D drugs, the following:
(A) A cost-effective drug utilization
management program, including incentives to
reduce costs when medically appropriate, such
as through the use of multiple source drugs (as
defined in section 1927(k)(7)(A)(i)).
(B) Quality assurance measures and systems to
reduce medication errors and adverse drug
interactions and improve medication use.
(C) A medication therapy management program
described in paragraph (2).
(D) A program to control fraud, abuse, and
waste.
(E) A utilization management tool to prevent
drug abuse (as described in paragraph (6)(A)).
Nothing in this section shall be construed as impairing
a PDP sponsor from utilizing cost management tools
(including differential payments) under all methods of
operation.
(2) Medication therapy management program.--
(A) Description.--
(i) In general.--A medication therapy
management program described in this
paragraph is a program of drug therapy
management that may be furnished by a
pharmacist and that is designed to
assure, with respect to targeted
beneficiaries described in clause (ii),
that covered part D drugs under the
prescription drug plan are
appropriately used to optimize
therapeutic outcomes through improved
medication use, and to reduce the risk
of adverse events, including adverse
drug interactions. Such a program may
distinguish between services in
ambulatory and institutional settings.
(ii) Targeted beneficiaries
described.--Targeted beneficiaries
described in this clause are part D
eligible individuals who--
(I) have multiple chronic
diseases (such as diabetes,
asthma, hypertension,
hyperlipidemia, and congestive
heart failure);
(II) are taking multiple
covered part D drugs; and
(III) are identified as
likely to incur annual costs
for covered part D drugs that
exceed a level specified by the
Secretary.
(B) Elements.--Such program may include
elements that promote--
(i) enhanced enrollee understanding
to promote the appropriate use of
medications by enrollees and to reduce
the risk of potential adverse events
associated with medications, through
beneficiary education, counseling, and
other appropriate means;
(ii) increased enrollee adherence
with prescription medication regimens
through medication refill reminders,
special packaging, and other compliance
programs and other appropriate means;
and
(iii) detection of adverse drug
events and patterns of overuse and
underuse of prescription drugs.
(C) Required interventions.--For plan years
beginning on or after the date that is 2 years
after the date of the enactment of the Patient
Protection and Affordable Care Act,
prescription drug plan sponsors shall offer
medication therapy management services to
targeted beneficiaries described in
subparagraph (A)(ii) that include, at a
minimum, the following to increase adherence to
prescription medications or other goals deemed
necessary by the Secretary:
(i) An annual comprehensive
medication review furnished person-to-
person or using telehealth technologies
(as defined by the Secretary) by a
licensed pharmacist or other qualified
provider. The comprehensive medication
review--
(I) shall include a review of
the individual's medications
and may result in the creation
of a recommended medication
action plan or other actions in
consultation with the
individual and with input from
the prescriber to the extent
necessary and practicable; and
(II) shall include providing
the individual with a written
or printed summary of the
results of the review.
The Secretary, in consultation with
relevant stakeholders, shall develop a
standardized format for the action plan
under subclause (I) and the summary
under subclause (II).
(ii) Follow-up interventions as
warranted based on the findings of the
annual medication review or the
targeted medication enrollment and
which may be provided person-to-person
or using telehealth technologies (as
defined by the Secretary).
(D) Assessment.--The prescription drug plan
sponsor shall have in place a process to
assess, at least on a quarterly basis, the
medication use of individuals who are at risk
but not enrolled in the medication therapy
management program, including individuals who
have experienced a transition in care, if the
prescription drug plan sponsor has access to
that information.
(E) Automatic enrollment with ability to opt-
out.--The prescription drug plan sponsor shall
have in place a process to--
(i) subject to clause (ii),
automatically enroll targeted
beneficiaries described in subparagraph
(A)(ii), including beneficiaries
identified under subparagraph (D), in
the medication therapy management
program required under this subsection;
and
(ii) permit such beneficiaries to
opt-out of enrollment in such program.
(E) Development of program in cooperation
with licensed pharmacists.--Such program shall
be developed in cooperation with licensed and
practicing pharmacists and physicians.
(F) Coordination with care management
plans.--The Secretary shall establish
guidelines for the coordination of any
medication therapy management program under
this paragraph with respect to a targeted
beneficiary with any care management plan
established with respect to such beneficiary
under a chronic care improvement program under
section 1807.
(G) Considerations in pharmacy fees.--The PDP
sponsor of a prescription drug plan shall take
into account, in establishing fees for
pharmacists and others providing services under
such plan, the resources used, and time
required to, implement the medication therapy
management program under this paragraph. Each
such sponsor shall disclose to the Secretary
upon request the amount of any such management
or dispensing fees. The provisions of section
1927(b)(3)(D) apply to information disclosed
under this subparagraph.
(3) Reducing wasteful dispensing of outpatient
prescription drugs in long-term care facilities.--The
Secretary shall require PDP sponsors of prescription
drug plans to utilize specific, uniform dispensing
techniques, as determined by the Secretary, in
consultation with relevant stakeholders (including
representatives of nursing facilities, residents of
nursing facilities, pharmacists, the pharmacy industry
(including retail and long-term care pharmacy),
prescription drug plans, MA-PD plans, and any other
stakeholders the Secretary determines appropriate),
such as weekly, daily, or automated dose dispensing,
when dispensing covered part D drugs to enrollees who
reside in a long-term care facility in order to reduce
waste associated with 30-day fills.
(4) Requiring valid prescriber national provider
identifiers on pharmacy claims.--
(A) In general.--For plan year 2016 and
subsequent plan years, the Secretary shall
require a claim for a covered part D drug for a
part D eligible individual enrolled in a
prescription drug plan under this part or an
MA-PD plan under part C to include a prescriber
National Provider Identifier that is determined
to be valid under the procedures established
under subparagraph (B)(i).
(B) Procedures.--
(i) Validity of prescriber national
provider identifiers.--The Secretary,
in consultation with appropriate
stakeholders, shall establish
procedures for determining the validity
of prescriber National Provider
Identifiers under subparagraph (A).
(ii) Informing beneficiaries of
reason for denial.--The Secretary shall
establish procedures to ensure that, in
the case that a claim for a covered
part D drug of an individual described
in subparagraph (A) is denied because
the claim does not meet the
requirements of this paragraph, the
individual is properly informed at the
point of service of the reason for the
denial.
(C) Report.--Not later than January 1, 2018,
the Inspector General of the Department of
Health and Human Services shall submit to
Congress a report on the effectiveness of the
procedures established under subparagraph
(B)(i).
(5) Drug management program for at-risk
beneficiaries.--
(A) Authority to establish.--A PDP sponsor
may establish a drug management program for at-
risk beneficiaries under which, subject to
subparagraph (B), the PDP sponsor may, in the
case of an at-risk beneficiary for prescription
drug abuse who is an enrollee in a prescription
drug plan of such PDP sponsor, limit such
beneficiary's access to coverage for frequently
abused drugs under such plan to frequently
abused drugs that are prescribed for such
beneficiary by one or more prescribers selected
under subparagraph (D), and dispensed for such
beneficiary by one or more pharmacies selected
under such subparagraph.
(B) Requirement for notices.--
(i) In general.--A PDP sponsor may
not limit the access of an at-risk
beneficiary for prescription drug abuse
to coverage for frequently abused drugs
under a prescription drug plan until
such sponsor--
(I) provides to the
beneficiary an initial notice
described in clause (ii) and a
second notice described in
clause (iii); and
(II) verifies with the
providers of the beneficiary
that the beneficiary is an at-
risk beneficiary for
prescription drug abuse.
(ii) Initial notice.--An initial
notice described in this clause is a
notice that provides to the
beneficiary--
(I) notice that the PDP
sponsor has identified the
beneficiary as potentially
being an at-risk beneficiary
for prescription drug abuse;
(II) information describing
all State and Federal public
health resources that are
designed to address
prescription drug abuse to
which the beneficiary has
access, including mental health
services and other counseling
services;
(III) notice of, and
information about, the right of
the beneficiary to appeal such
identification under subsection
(h) and the option of an
automatic escalation to
external review;
(IV) a request for the
beneficiary to submit to the
PDP sponsor preferences for
which prescribers and
pharmacies the beneficiary
would prefer the PDP sponsor to
select under subparagraph (D)
in the case that the
beneficiary is identified as an
at-risk beneficiary for
prescription drug abuse as
described in clause (iii)(I);
(V) an explanation of the
meaning and consequences of the
identification of the
beneficiary as potentially
being an at-risk beneficiary
for prescription drug abuse,
including an explanation of the
drug management program
established by the PDP sponsor
pursuant to subparagraph (A);
(VI) clear instructions that
explain how the beneficiary can
contact the PDP sponsor in
order to submit to the PDP
sponsor the preferences
described in subclause (IV) and
any other communications
relating to the drug management
program for at-risk
beneficiaries established by
the PDP sponsor; and
(VII) contact information for
other organizations that can
provide the beneficiary with
assistance regarding such drug
management program (similar to
the information provided by the
Secretary in other standardized
notices provided to part D
eligible individuals enrolled
in prescription drug plans
under this part).
(iii) Second notice.--A second notice
described in this clause is a notice
that provides to the beneficiary
notice--
(I) that the PDP sponsor has
identified the beneficiary as
an at-risk beneficiary for
prescription drug abuse;
(II) that such beneficiary is
subject to the requirements of
the drug management program for
at-risk beneficiaries
established by such PDP sponsor
for such plan;
(III) of the prescriber (or
prescribers) and pharmacy (or
pharmacies) selected for such
individual under subparagraph
(D);
(IV) of, and information
about, the beneficiary's right
to appeal such identification
under subsection (h) and the
option of an automatic
escalation to external review;
(V) that the beneficiary can,
in the case that the
beneficiary has not previously
submitted to the PDP sponsor
preferences for which
prescribers and pharmacies the
beneficiary would prefer the
PDP sponsor select under
subparagraph (D), submit such
preferences to the PDP sponsor;
and
(VI) that includes clear
instructions that explain how
the beneficiary can contact the
PDP sponsor.
(iv) Timing of notices.--
(I) In general.--Subject to
subclause (II), a second notice
described in clause (iii) shall
be provided to the beneficiary
on a date that is not less than
30 days after an initial notice
described in clause (ii) is
provided to the beneficiary.
(II) Exception.--In the case
that the PDP sponsor, in
conjunction with the Secretary,
determines that concerns
identified through rulemaking
by the Secretary regarding the
health or safety of the
beneficiary or regarding
significant drug diversion
activities require the PDP
sponsor to provide a second
notice described in clause
(iii) to the beneficiary on a
date that is earlier than the
date described in subclause
(I), the PDP sponsor may
provide such second notice on
such earlier date.
(C) At-risk beneficiary for prescription drug
abuse.--
(i) In general.--For purposes of this
paragraph, the term ``at-risk
beneficiary for prescription drug
abuse'' means a part D eligible
individual who is not an exempted
individual described in clause (ii)
and--
(I) who is identified as such
an at-risk beneficiary through
the use of clinical guidelines
that indicate misuse or abuse
of prescription drugs described
in subparagraph (G) and that
are developed by the Secretary
in consultation with PDP
sponsors and other
stakeholders, including
individuals entitled to
benefits under part A or
enrolled under part B, advocacy
groups representing such
individuals, physicians,
pharmacists, and other
clinicians, retail pharmacies,
plan sponsors, entities
delegated by plan sponsors, and
biopharmaceutical
manufacturers; or
(II) with respect to whom the
PDP sponsor of a prescription
drug plan, upon enrolling such
individual in such plan,
received notice from the
Secretary that such individual
was identified under this
paragraph to be an at-risk
beneficiary for prescription
drug abuse under the
prescription drug plan in which
such individual was most
recently previously enrolled
and such identification has not
been terminated under
subparagraph (F).
(ii) Exempted individual described.--
An exempted individual described in
this clause is an individual who--
(I) receives hospice care
under this title;
(II) is a resident of a long-
term care facility, of a
facility described in section
1905(d), or of another facility
for which frequently abused
drugs are dispensed for
residents through a contract
with a single pharmacy; or
(III) the Secretary elects to
treat as an exempted individual
for purposes of clause (i).
(iii) Program size.--The Secretary
shall establish policies, including the
guidelines developed under clause
(i)(I) and the exemptions under clause
(ii)(III), to ensure that the
population of enrollees in a drug
management program for at-risk
beneficiaries operated by a
prescription drug plan can be
effectively managed by such plans.
(iv) Clinical contact.--With respect
to each at-risk beneficiary for
prescription drug abuse enrolled in a
prescription drug plan offered by a PDP
sponsor, the PDP sponsor shall contact
the beneficiary's providers who have
prescribed frequently abused drugs
regarding whether prescribed
medications are appropriate for such
beneficiary's medical conditions.
(D) Selection of prescribers and
pharmacies.--
(i) In general.--With respect to each
at-risk beneficiary for prescription
drug abuse enrolled in a prescription
drug plan offered by such sponsor, a
PDP sponsor shall, based on the
preferences submitted to the PDP
sponsor by the beneficiary pursuant to
clauses (ii)(IV) and (iii)(V) of
subparagraph (B) (except as otherwise
provided in this subparagraph) select--
(I) one, or, if the PDP
sponsor reasonably determines
it necessary to provide the
beneficiary with reasonable
access under clause (ii), more
than one, individual who is
authorized to prescribe
frequently abused drugs
(referred to in this paragraph
as a ``prescriber'') who may
write prescriptions for such
drugs for such beneficiary; and
(II) one, or, if the PDP
sponsor reasonably determines
it necessary to provide the
beneficiary with reasonable
access under clause (ii), more
than one, pharmacy that may
dispense such drugs to such
beneficiary.
For purposes of subclause (II), in the
case of a pharmacy that has multiple
locations that share real-time
electronic data, all such locations of
the pharmacy shall collectively be
treated as one pharmacy.
(ii) Reasonable access.--In making
the selections under this
subparagraph--
(I) a PDP sponsor shall
ensure that the beneficiary
continues to have reasonable
access to frequently abused
drugs (as defined in
subparagraph (G)), taking into
account geographic location,
beneficiary preference, impact
on costsharing, and reasonable
travel time; and
(II) a PDP sponsor shall
ensure such access (including
access to prescribers and
pharmacies with respect to
frequently abused drugs) in the
case of individuals with
multiple residences, in the
case of natural disasters and
similar situations, and in the
case of the provision of
emergency services.
(iii) Beneficiary preferences.--If an
at-risk beneficiary for prescription
drug abuse submits preferences for
which in-network prescribers and
pharmacies the beneficiary would prefer
the PDP sponsor select in response to a
notice under subparagraph (B), the PDP
sponsor shall--
(I) review such preferences;
(II) select or change the
selection of prescribers and
pharmacies for the beneficiary
based on such preferences; and
(III) inform the beneficiary
of such selection or change of
selection.
(iv) Exception regarding beneficiary
preferences.--In the case that the PDP
sponsor determines that a change to the
selection of prescriber or pharmacy
under clause (iii)(II) by the PDP
sponsor is contributing or would
contribute to prescription drug abuse
or drug diversion by the beneficiary,
the PDP sponsor may change the
selection of prescriber or pharmacy for
the beneficiary without regard to the
preferences of the beneficiary
described in clause (iii). If the PDP
sponsor changes the selection pursuant
to the preceding sentence, the PDP
sponsor shall provide the beneficiary
with--
(I) at least 30 days written
notice of the change of
selection; and
(II) a rationale for the
change.
(v) Confirmation.--Before selecting a
prescriber or pharmacy under this
subparagraph, a PDP sponsor must notify
the prescriber and pharmacy that the
beneficiary involved has been
identified for inclusion in the drug
management program for at-risk
beneficiaries and that the prescriber
and pharmacy has been selected as the
beneficiary's designated prescriber and
pharmacy.
(E) Terminations and appeals.--The
identification of an individual as an at-risk
beneficiary for prescription drug abuse under
this paragraph, a coverage determination made
under a drug management program for at-risk
beneficiaries, the selection of prescriber or
pharmacy under subparagraph (D), and
information to be shared under subparagraph
(I), with respect to such individual, shall be
subject to reconsideration and appeal under
subsection (h) and the option of an automatic
escalation to external review to the extent
provided by the Secretary.
(F) Termination of identification.--
(i) In general.--The Secretary shall
develop standards for the termination
of identification of an individual as
an at-risk beneficiary for prescription
drug abuse under this paragraph. Under
such standards such identification
shall terminate as of the earlier of--
(I) the date the individual
demonstrates that the
individual is no longer likely,
in the absence of the
restrictions under this
paragraph, to be an at-risk
beneficiary for prescription
drug abuse described in
subparagraph (C)(i); and
(II) the end of such maximum
period of identification as the
Secretary may specify.
(ii) Rule of construction.--Nothing
in clause (i) shall be construed as
preventing a plan from identifying an
individual as an at-risk beneficiary
for prescription drug abuse under
subparagraph (C)(i) after such
termination on the basis of additional
information on drug use occurring after
the date of notice of such termination.
(G) Frequently abused drug.--For purposes of
this subsection, the term ``frequently abused
drug'' means a drug that is a controlled
substance that the Secretary determines to be
frequently abused or diverted.
(H) Data disclosure.--
(i) Data on decision to impose
limitation.--In the case of an at-risk
beneficiary for prescription drug abuse
(or an individual who is a potentially
at-risk beneficiary for prescription
drug abuse) whose access to coverage
for frequently abused drugs under a
prescription drug plan has been limited
by a PDP sponsor under this paragraph,
the Secretary shall establish rules and
procedures to require the PDP sponsor
to disclose data, including any
necessary individually identifiable
health information, in a form and
manner specified by the Secretary,
about the decision to impose such
limitations and the limitations imposed
by the sponsor under this part.
(ii) Data to reduce fraud, abuse, and
waste.--The Secretary shall establish
rules and procedures to require PDP
sponsors operating a drug management
program for at-risk beneficiaries under
this paragraph to provide the Secretary
with such data as the Secretary
determines appropriate for purposes of
identifying patterns of prescription
drug utilization for plan enrollees
that are outside normal patterns and
that may indicate fraudulent, medically
unnecessary, or unsafe use.
(I) Sharing of information for subsequent
plan enrollments.--The Secretary shall
establish procedures under which PDP sponsors
who offer prescription drug plans shall share
information with respect to individuals who are
at-risk beneficiaries for prescription drug
abuse (or individuals who are potentially at-
risk beneficiaries for prescription drug abuse)
and enrolled in a prescription drug plan and
who subsequently disenroll from such plan and
enroll in another prescription drug plan
offered by another PDP sponsor.
(J) Privacy issues.--Prior to the
implementation of the rules and procedures
under this paragraph, the Secretary shall
clarify privacy requirements, including
requirements under the regulations promulgated
pursuant to section 264(c) of the Health
Insurance Portability and Accountability Act of
1996 (42 U.S.C. 1320d-2 note), related to the
sharing of data under subparagraphs (H) and (I)
by PDP sponsors. Such clarification shall
provide that the sharing of such data shall be
considered to be protected health information
in accordance with the requirements of the
regulations promulgated pursuant to such
section 264(c).
(K) Education.--The Secretary shall provide
education to enrollees in prescription drug
plans of PDP sponsors and providers regarding
the drug management program for at-risk
beneficiaries described in this paragraph,
including education--
(i) provided by Medicare
administrative contractors through the
improper payment outreach and education
program described in section 1874A(h);
and
(ii) through current education
efforts (such as State health insurance
assistance programs described in
subsection (a)(1)(A) of section 119 of
the Medicare Improvements for Patients
and Providers Act of 2008 (42 U.S.C.
1395b-3 note)) and materials directed
toward such enrollees.
(L) Application under ma-pd plans.--Pursuant
to section 1860D-21(c)(1), the provisions of
this paragraph apply under part D to MA
organizations offering MA-PD plans to MA
eligible individuals in the same manner as such
provisions apply under this part to a PDP
sponsor offering a prescription drug plan to a
part D eligible individual.
(M) CMS compliance review.--The Secretary
shall ensure that existing plan sponsor
compliance reviews and audit processes include
the drug management programs for at-risk
beneficiaries under this paragraph, including
appeals processes under such programs.
(6) Utilization management tool to prevent drug
abuse.--
(A) In general.--A tool described in this
paragraph is any of the following:
(i) A utilization tool designed to
prevent the abuse of frequently abused
drugs by individuals and to prevent the
diversion of such drugs at pharmacies.
(ii) Retrospective utilization review
to identify--
(I) individuals that receive
frequently abused drugs at a
frequency or in amounts that
are not clinically appropriate;
and
(II) providers of services or
suppliers that may facilitate
the abuse or diversion of
frequently abused drugs by
beneficiaries.
(iii) Consultation with the
contractor described in subparagraph
(B) to verify if an individual
enrolling in a prescription drug plan
offered by a PDP sponsor has been
previously identified by another PDP
sponsor as an individual described in
clause (ii)(I).
(B) Reporting.--A PDP sponsor offering a
prescription drug plan (and an MA organization
offering an MA-PD plan) in a State shall submit
to the Secretary and the Medicare drug
integrity contractor with which the Secretary
has entered into a contract under section 1893
with respect to such State a report, on a
monthly basis, containing information on--
(i) any provider of services or
supplier described in subparagraph
(A)(ii)(II) that is identified by such
plan sponsor (or organization) during
the 30-day period before such report is
submitted; and
(ii) the name and prescription
records of individuals described in
paragraph (5)(C).
(C) CMS compliance review.--The Secretary
shall ensure that plan sponsor compliance
reviews and program audits biennially include a
certification that utilization management tools
under this paragraph are in compliance with the
requirements for such tools.
(6) Providing prescription drug plans with parts a
and b claims data to promote the appropriate use of
medications and improve health outcomes.--
(A) Process.--Subject to subparagraph (B),
the Secretary shall establish a process under
which a PDP sponsor of a prescription drug plan
may submit a request for the Secretary to
provide the sponsor, on a periodic basis and in
an electronic format, beginning in plan year
2020, data described in subparagraph (D) with
respect to enrollees in such plan. Such data
shall be provided without regard to whether
such enrollees are described in clause (ii) of
paragraph (2)(A).
(B) Purposes.--A PDP sponsor may use the data
provided to the sponsor pursuant to
subparagraph (A) for any of the following
purposes:
(i) To optimize therapeutic outcomes
through improved medication use, as
such phrase is used in clause (i) of
paragraph (2)(A).
(ii) To improving care coordination
so as to prevent adverse health
outcomes, such as preventable emergency
department visits and hospital
readmissions.
(iii) For any other purpose
determined appropriate by the
Secretary.
(C) Limitations on data use.--A PDP sponsor
shall not use data provided to the sponsor
pursuant to subparagraph (A) for any of the
following purposes:
(i) To inform coverage determinations
under this part.
(ii) To conduct retroactive reviews
of medically accepted indications
determinations.
(iii) To facilitate enrollment
changes to a different prescription
drug plan or an MA-PD plan offered by
the same parent organization.
(iv) To inform marketing of benefits.
(v) For any other purpose that the
Secretary determines is necessary to
include in order to protect the
identity of individuals entitled to, or
enrolled for, benefits under this title
and to protect the security of personal
health information.
(D) Data described.--The data described in
this clause are standardized extracts (as
determined by the Secretary) of claims data
under parts A and B for items and services
furnished under such parts for time periods
specified by the Secretary. Such data shall
include data as current as practicable.
(d) Consumer Satisfaction Surveys.--In order to provide for
comparative information under section 1860D-1(c)(3)(A)(v), the
Secretary shall conduct consumer satisfaction surveys with
respect to PDP sponsors and prescription drug plans in a manner
similar to the manner such surveys are conducted for MA
organizations and MA plans under part C.
(e) Electronic Prescription Program.--
(1) Application of standards.--As of such date as the
Secretary may specify, but not later than 1 year after
the date of promulgation of final standards under
paragraph (4)(D), prescriptions and other information
described in paragraph (2)(A) for covered part D drugs
prescribed for part D eligible individuals that are
transmitted electronically shall be transmitted only in
accordance with such standards under an electronic
prescription drug program that meets the requirements
of paragraph (2).
(2) Program requirements.--Consistent with uniform
standards established under paragraph (3)--
(A) Provision of information to prescribing
health care professional and dispensing
pharmacies and pharmacists.--An electronic
prescription drug program shall provide for the
electronic transmittal to the prescribing
health care professional and to the dispensing
pharmacy and pharmacist of the prescription and
information on eligibility and benefits
(including the drugs included in the applicable
formulary, any tiered formulary structure, and
any requirements for prior authorization) and
of the following information with respect to
the prescribing and dispensing of a covered
part D drug:
(i) Information on the drug being
prescribed or dispensed and other drugs
listed on the medication history,
including information on drug-drug
interactions, warnings or cautions,
and, when indicated, dosage
adjustments.
(ii) Information on the availability
of lower cost, therapeutically
appropriate alternatives (if any) for
the drug prescribed.
(B) Application to medical history
information.--Effective on and after such date
as the Secretary specifies and after the
establishment of appropriate standards to carry
out this subparagraph, the program shall
provide for the electronic transmittal in a
manner similar to the manner under subparagraph
(A) of information that relates to the medical
history concerning the individual and related
to a covered part D drug being prescribed or
dispensed, upon request of the professional or
pharmacist involved.
(C) Limitations.--Information shall only be
disclosed under subparagraph (A) or (B) if the
disclosure of such information is permitted
under the Federal regulations (concerning the
privacy of individually identifiable health
information) promulgated under section 264(c)
of the Health Insurance Portability and
Accountability Act of 1996.
(D) Timing.--To the extent feasible, the
information exchanged under this paragraph
shall be on an interactive, real-time basis.
(3) Standards.--
(A) In general.--The Secretary shall provide
consistent with this subsection for the
promulgation of uniform standards relating to
the requirements for electronic prescription
drug programs under paragraph (2).
(B) Objectives.--Such standards shall be
consistent with the objectives of improving--
(i) patient safety;
(ii) the quality of care provided to
patients; and
(iii) efficiencies, including cost
savings, in the delivery of care.
(C) Design criteria.--Such standards shall--
(i) be designed so that, to the
extent practicable, the standards do
not impose an undue administrative
burden on prescribing health care
professionals and dispensing pharmacies
and pharmacists;
(ii) be compatible with standards
established under part C of title XI,
standards established under subsection
(b)(2)(B)(i), and with general health
information technology standards; and
(iii) be designed so that they permit
electronic exchange of drug labeling
and drug listing information maintained
by the Food and Drug Administration and
the National Library of Medicine.
(D) Permitting use of appropriate
messaging.--Such standards shall allow for the
messaging of information only if it relates to
the appropriate prescribing of drugs, including
quality assurance measures and systems referred
to in subsection (c)(1)(B).
(E) Permitting patient designation of
dispensing pharmacy.--
(i) In general.--Consistent with
clause (ii), such standards shall
permit a part D eligible individual to
designate a particular pharmacy to
dispense a prescribed drug.
(ii) No change in benefits.--Clause
(i) shall not be construed as
affecting--
(I) the access required to be
provided to pharmacies by a
prescription drug plan; or
(II) the application of any
differences in benefits or
payments under such a plan
based on the pharmacy
dispensing a covered part D
drug.
(4) Development, promulgation, and modification of
standards.--
(A) Initial standards.--Not later than
September 1, 2005, the Secretary shall develop,
adopt, recognize, or modify initial uniform
standards relating to the requirements for
electronic prescription drug programs described
in paragraph (2) taking into consideration the
recommendations (if any) from the National
Committee on Vital and Health Statistics (as
established under section 306(k) of the Public
Health Service Act (42 U.S.C. 242k(k))) under
subparagraph (B).
(B) Role of ncvhs.--The National Committee on
Vital and Health Statistics shall develop
recommendations for uniform standards relating
to such requirements in consultation with the
following:
(i) Standard setting organizations
(as defined in section 1171(8))
(ii) Practicing physicians.
(iii) Hospitals.
(iv) Pharmacies.
(v) Practicing pharmacists.
(vi) Pharmacy benefit managers.
(vii) State boards of pharmacy.
(viii) State boards of medicine.
(ix) Experts on electronic
prescribing.
(x) Other appropriate Federal
agencies.
(C) Pilot project to test initial
standards.--
(i) In general.--During the 1-year
period that begins on January 1, 2006,
the Secretary shall conduct a pilot
project to test the initial standards
developed under subparagraph (A) prior
to the promulgation of the final
uniform standards under subparagraph
(D) in order to provide for the
efficient implementation of the
requirements described in paragraph
(2).
(ii) Exception.--Pilot testing of
standards is not required under clause
(i) where there already is adequate
industry experience with such
standards, as determined by the
Secretary after consultation with
effected standard setting organizations
and industry users.
(iii) Voluntary participation of
physicians and pharmacies.--In order to
conduct the pilot project under clause
(i), the Secretary shall enter into
agreements with physicians, physician
groups, pharmacies, hospitals, PDP
sponsors, MA organizations, and other
appropriate entities under which health
care professionals electronically
transmit prescriptions to dispensing
pharmacies and pharmacists in
accordance with such standards.
(iv) Evaluation and report.--
(I) Evaluation.--The
Secretary shall conduct an
evaluation of the pilot project
conducted under clause (i).
(II) Report to congress.--Not
later than April 1, 2007, the
Secretary shall submit to
Congress a report on the
evaluation conducted under
subclause (I).
(D) Final standards.--Based upon the
evaluation of the pilot project under
subparagraph (C)(iv)(I) and not later than
April 1, 2008, the Secretary shall promulgate
uniform standards relating to the requirements
described in paragraph (2).
(5) Relation to state laws.--The standards
promulgated under this subsection shall supersede any
State law or regulation that--
(A) is contrary to the standards or restricts
the ability to carry out this part; and
(B) pertains to the electronic transmission
of medication history and of information on
eligibility, benefits, and prescriptions with
respect to covered part D drugs under this
part.
(6) Establishment of safe harbor.--The Secretary, in
consultation with the Attorney General, shall
promulgate regulations that provide for a safe harbor
from sanctions under paragraphs (1) and (2) of section
1128B(b) and an exception to the prohibition under
subsection (a)(1) of section 1877 with respect to the
provision of nonmonetary remuneration (in the form of
hardware, software, or information technology and
training services) necessary and used solely to receive
and transmit electronic prescription information in
accordance with the standards promulgated under this
subsection--
(A) in the case of a hospital, by the
hospital to members of its medical staff;
(B) in the case of a group practice (as
defined in section 1877(h)(4)), by the practice
to prescribing health care professionals who
are members of such practice; and
(C) in the case of a PDP sponsor or MA
organization, by the sponsor or organization to
pharmacists and pharmacies participating in the
network of such sponsor or organization, and to
prescribing health care professionals.
(7) Requirement of e-prescribing for controlled
substances.--
(A) In general.--Subject to subparagraph (B),
a prescription for a covered part D drug under
a prescription drug plan (or under an MA-PD
plan) for a schedule II, III, IV, or V
controlled substance shall be transmitted by a
health care practitioner electronically in
accordance with an electronic prescription drug
program that meets the requirements of
paragraph (2).
(B) Exception for certain circumstances.--The
Secretary shall, pursuant to rulemaking,
specify circumstances with respect to which the
Secretary may waive the requirement under
subparagraph (A), with respect to a covered
part D drug, including in the case of--
(i) a prescription issued when the
practitioner and dispenser are the same
entity;
(ii) a prescription issued that
cannot be transmitted electronically
under the most recently implemented
version of the National Council for
Prescription Drug Programs SCRIPT
Standard;
(iii) a prescription issued by a
practitioner who has received a waiver
or a renewal thereof for a specified
period determined by the Secretary, not
to exceed one year, from the
requirement to use electronic
prescribing, pursuant to a process
established by regulation by the
Secretary, due to demonstrated economic
hardship, technological limitations
that are not reasonably within the
control of the practitioner, or other
exceptional circumstance demonstrated
by the practitioner;
(iv) a prescription issued by a
practitioner under circumstances in
which, notwithstanding the
practitioner's ability to submit a
prescription electronically as required
by this subsection, such practitioner
reasonably determines that it would be
impractical for the individual involved
to obtain substances prescribed by
electronic prescription in a timely
manner, and such delay would adversely
impact the individual's medical
condition involved;
(v) a prescription issued by a
practitioner allowing for the
dispensing of a non-patient specific
prescription pursuant to a standing
order, approved protocol for drug
therapy, collaborative drug management,
or comprehensive medication management,
in response to a public health
emergency, or other circumstances where
the practitioner may issue a non-
patient specific prescription;
(vi) a prescription issued by a
practitioner prescribing a drug under a
research protocol;
(vii) a prescription issued by a
practitioner for a drug for which the
Food and Drug Administration requires a
prescription to contain elements that
are not able to be included in
electronic prescribing, such as a drug
with risk evaluation and mitigation
strategies that include elements to
assure safe use; and
(viii) a prescription issued by a
practitioner for an individual who--
(I) receives hospice care
under this title; or
(II) is a resident of a
skilled nursing facility (as
defined in section 1819(a)), or
a medical institution or
nursing facility for which
payment is made for an
institutionalized individual
under section 1902(q)(1)(B),
for which frequently abused
drugs are dispensed for
residents through a contract
with a single pharmacy, as
determined by the Secretary in
accordance with this paragraph.
(C) Dispensing.--Nothing in this paragraph
shall be construed as requiring a sponsor of a
prescription drug plan under this part, MA
organization offering an MA-PD plan under part
C, or a pharmacist to verify that a
practitioner, with respect to a prescription
for a covered part D drug, has a waiver (or is
otherwise exempt) under subparagraph (B) from
the requirement under subparagraph (A). Nothing
in this paragraph shall be construed as
affecting the ability of the plan to cover or
the pharmacists' ability to continue to
dispense covered part D drugs from otherwise
valid written, oral or fax prescriptions that
are consistent with laws and regulations.
Nothing in this paragraph shall be construed as
affecting the ability of the beneficiary
involved to designate a particular pharmacy to
dispense a prescribed drug to the extent
consistent with the requirements under
subsection (b)(1) and under this paragraph.
(D) Enforcement.--The Secretary shall,
pursuant to rulemaking, have authority to
enforce and specify appropriate penalties for
non-compliance with the requirement under
subparagraph (A).
(f) Grievance Mechanism.--Each PDP sponsor shall provide
meaningful procedures for hearing and resolving grievances
between the sponsor (including any entity or individual through
which the sponsor provides covered benefits) and enrollees with
prescription drug plans of the sponsor under this part in
accordance with section 1852(f).
(g) Coverage Determinations and Reconsiderations.--
(1) Application of coverage determination and
reconsideration provisions.--A PDP sponsor shall meet
the requirements of paragraphs (1) through (3) of
section 1852(g) with respect to covered benefits under
the prescription drug plan it offers under this part in
the same manner as such requirements apply to an MA
organization with respect to benefits it offers under
an MA plan under part C.
(2) Request for a determination for the treatment of
tiered formulary drug.--In the case of a prescription
drug plan offered by a PDP sponsor that provides for
tiered cost-sharing for drugs included within a
formulary and provides lower cost-sharing for preferred
drugs included within the formulary, a part D eligible
individual who is enrolled in the plan may request an
exception to the tiered cost-sharing structure. Under
such an exception, a nonpreferred drug could be covered
under the terms applicable for preferred drugs if the
prescribing physician determines that the preferred
drug for treatment of the same condition either would
not be as effective for the individual or would have
adverse effects for the individual or both. A PDP
sponsor shall have an exceptions process under this
paragraph consistent with guidelines established by the
Secretary for making a determination with respect to
such a request. Denial of such an exception shall be
treated as a coverage denial for purposes of applying
subsection (h).
(h) Appeals.--
(1) In general.--Subject to paragraph (2), a PDP
sponsor shall meet the requirements of paragraphs (4)
and (5) of section 1852(g) with respect to benefits
(including a determination related to the application
of tiered cost-sharing described in subsection (g)(2))
in a manner similar (as determined by the Secretary) to
the manner such requirements apply to an MA
organization with respect to benefits under the
original medicare fee-for-service program option it
offers under an MA plan under part C. In applying this
paragraph only the part D eligible individual shall be
entitled to bring such an appeal.
(2) Limitation in cases on nonformulary
determinations.--A part D eligible individual who is
enrolled in a prescription drug plan offered by a PDP
sponsor may appeal under paragraph (1) a determination
not to provide for coverage of a covered part D drug
that is not on the formulary under the plan only if the
prescribing physician determines that all covered part
D drugs on any tier of the formulary for treatment of
the same condition would not be as effective for the
individual as the nonformulary drug, would have adverse
effects for the individual, or both.
(3) Treatment of nonformulary determinations.--If a
PDP sponsor determines that a plan provides coverage
for a covered part D drug that is not on the formulary
of the plan, the drug shall be treated as being
included on the formulary for purposes of section
1860D-2(b)(4)(C)(i).
(i) Privacy, Confidentiality, and Accuracy of Enrollee
Records.--The provisions of section 1852(h) shall apply to a
PDP sponsor and prescription drug plan in the same manner as it
applies to an MA organization and an MA plan.
(j) Treatment of Accreditation.--Subparagraph (A) of section
1852(e)(4) (relating to treatment of accreditation) shall apply
to a PDP sponsor under this part with respect to the following
requirements, in the same manner as it applies to an MA
organization with respect to the requirements in subparagraph
(B) (other than clause (vii) thereof) of such section:
(1) Subsection (b) of this section (relating to
access to covered part D drugs).
(2) Subsection (c) of this section (including quality
assurance and medication therapy management).
(3) Subsection (i) of this section (relating to
confidentiality and accuracy of enrollee records).
(k) Public Disclosure of Pharmaceutical Prices for Equivalent
Drugs.--
(1) In general.--A PDP sponsor offering a
prescription drug plan shall provide that each pharmacy
that dispenses a covered part D drug shall inform an
enrollee of any differential between the price of the
drug to the enrollee and the price of the lowest priced
generic covered part D drug under the plan that is
therapeutically equivalent and bioequivalent and
available at such pharmacy.
(2) Timing of notice.--
(A) In general.--Subject to subparagraph (B),
the information under paragraph (1) shall be
provided at the time of purchase of the drug
involved, or, in the case of dispensing by mail
order, at the time of delivery of such drug.
(B) Waiver.--The Secretary may waive
subparagraph (A) in such circumstances as the
Secretary may specify.
(l) Requirements with Respect to Sales and Marketing
Activities.--The following provisions shall apply to a PDP
sponsor (and the agents, brokers, and other third parties
representing such sponsor) in the same manner as such
provisions apply to a Medicare Advantage organization (and the
agents, brokers, and other third parties representing such
organization):
(1) The prohibition under section 1851(h)(4)(C) on
conducting activities described in section 1851(j)(1).
(2) The requirement under section 1851(h)(4)(D) to
conduct activities described in section 1851(j)(2) in
accordance with the limitations established under such
subsection.
(3) The inclusion of the plan type in the plan name
under section 1851(h)(6).
(4) The requirements regarding the appointment of
agents and brokers and compliance with State
information requests under subparagraphs (A) and (B),
respectively, of section 1851(h)(7).
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